43 results on '"Rosa, Regis G."'
Search Results
2. Mortality predictors in patients with suspected sepsis in the emergency department of a tertiary care hospital: a retrospective cohort study
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Bidart, João P. M., Rosa, Regis G., Bessel, Marina, Pedrotti, Luana G., and Goldani, Luciano Z.
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- 2024
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3. Navigating complex interventions in post-ICU care: insights from a randomized clinical trial of post-intensive care multidisciplinary consultations
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Rosa, Regis G. and Walsh, Timothy S.
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- 2024
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4. Effect of Apixaban on Clinical Outcomes in Outpatients With COVID-19: The APOLLO Randomized Clinical Trial
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de Barros e Silva, Pedro Gabriel Melo, Macedo, Ariane Vieira Scarlatelli, Bronhara, Bruna, Damiani, Lucas Petri, Mazza Barbosa, Lilian, Lopes, Nathália Rodrigues, Suiama, Mayra Akimi, Antunes, Murillo O., Gonçalves, Mariana Raquel, Gebara, Otávio Celso Eluf, de Aquino Martins, Priscilla, Ribeiro, Mariana Galvão, de Moura Xavier de Moraes, João Batista, Jr, Aguiar, Valéria Cristina Resende, Cavalcanti, Alexandre B., Rosa, Regis G., Berwanger, Otavio, Veiga, Viviane C., Azevedo, Luciano C.P., Ramacciotti, Eduardo, Granger, Christopher B., Alexander, John H., Avezum, Alvaro, and Lopes, Renato D.
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- 2024
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5. Antisense therapy to block the Kallikrein-kinin pathway in COVID-19: The ASKCOV randomized controlled trial
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Zampieri, Fernando G., Westphal, Glauco Adrieno, Santos, Maria Adelaide Dos, Gomes, Samara P.C., Gomes, Jackeline O., Negrelli, Karina L., Santos, Renato H.N., Ishihara, Luciana M., Miranda, Tamiris A., Laranjeira, Ligia N., Valeis, Nanci, Santucci, Eliana Vieira, de Souza Dantas, Vicente Cés, Gebara, Otávio, Cohn, Danny M., Buchele, Gustavo, Janiszewski, Mariano, de Freitas, Flávio Geraldo, Dal-Pizzol, Felipe, de Matos Soeiro, Alexandre, Berti, Isabele Ribeiro, Germano, Almir, Schettini, Daniel Almeida, Rosa, Regis G., Falavigna, Maicon, Veiga, Viviane C., Azevedo, Luciano C.P., Damiani, Lucas P., Machado, Flávia R., and Cavalcanti, Alexandre B.
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- 2024
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6. Cardiovascular Safety of Azithromycin in Patients Hospitalized With COVID-19: A Prespecified Pooled Analysis of the COALITION I and COALITION II Randomized Clinical Trials
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Furtado, Remo H.M., Barros e Silva, Pedro G.M., Fonseca, Henrique A.R., Serpa-Neto, Ary, Correa, Thiago D., Guimarães, Hélio P., Pereira, Adriano J., Olivato, Guilherme B., Zampieri, Fernando G., Lisboa, Thiago, Junqueira, Debora L.M., Lapa, Maura G., Monfardini, Frederico, Damiani, Lucas P., Echenique, Leandro S., Gebara, Otavio E., Hoffman Filho, Conrado R., Polanczyk, Carisi A, Rohde, Luis E., Amazonas, Roberto, Machado, Flávia R., Avezum, Alvaro, Azevedo, Luciano C.P., Veiga, Viviane C., Rosa, Regis G., Lopes, Renato D., Cavalcanti, Alexandre B., and Berwanger, Otavio
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- 2024
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7. Rivaroxaban to prevent major clinical outcomes in non-hospitalised patients with COVID-19: the CARE – COALITION VIII randomised clinical trial
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Avezum, Álvaro, Oliveira Junior, Haliton Alves, Neves, Precil Diego M.M., Alves, Lucas Bassolli O., Cavalcanti, Alexandre B., Rosa, Regis G., Veiga, Viviane C., Azevedo, Luciano C.P., Zimmermann, Sérgio Luiz, Silvestre, Odilson Marcos, Seabra Prudente, Raphael Cruz, Morales Kormann, Adrian Paulo, Moreira, Frederico Rafael, Boszczowski, Icaro, de Brito Sobrinho, Edgar, da Silva e Souza, André, Seligman, Renato, de Souza Paolino, Bruno, Razuk, Alvaro, Diogenes de Magalhaes Feitosa, Audes, Monteiro Belmonte, Pedro Luiz, Freitas das Neves Gonçalves, Priscila, Hernandes, Mauro Esteves, Fagundes, Ariovaldo Leal, Sarmet Esteves, José Maria, Tognon, Alexandre Pereira, Eikelboom, John, Berwanger, Otávio, Lopes, Renato D., and Oliveira, Gustavo B.F.
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- 2023
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8. Hydroxychloroquine versus placebo in the treatment of non-hospitalised patients with COVID-19 (COPE – Coalition V): A double-blind, multicentre, randomised, controlled trial
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Avezum, Álvaro, Oliveira, Gustavo B F, Oliveira, Haliton, Lucchetta, Rosa C, Pereira, Valéria F A, Dabarian, André L, D´O Vieira, Ricardo, Silva, Daniel V, Kormann, Adrian P M, Tognon, Alexandre P, De Gasperi, Ricardo, Hernandes, Mauro E, Feitosa, Audes D M, Piscopo, Agnaldo, Souza, André S, Miguel, Carlos H, Nogueira, Vinicius O, Minelli, César, Magalhães, Carlos C, Morejon, Karen M L, Bicudo, Letícia S, Souza, Germano E C, Gomes, Marco A M, Fo, José J F Raposo, Schwarzbold, Alexandre V, Zilli, Alexandre, Amazonas, Roberto B, Moreira, Frederico R, Alves, Lucas B O, Assis, Silvia R L, Neves, Precil D M M, Matuoka, Jessica Y, Boszczowski, Icaro, Catarino, Daniela G M, Veiga, Viviane C, Azevedo, Luciano C P, Rosa, Regis G, Lopes, Renato D, Cavalcanti, Alexandre B, and Berwanger, Otavio
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- 2022
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9. Randomized clinical trial to evaluate a routine full anticoagulation Strategy in Patients with Coronavirus Infection (SARS-CoV2) admitted to hospital: Rationale and design of the ACTION (AntiCoagulaTlon cOroNavirus)–Coalition IV trial
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Lopes, Renato D., de Barros e Silva, Pedro Gabriel Melo, Furtado, Remo H.M., Macedo, Ariane Vieira Scarlatelli, Ramacciotti, Eduardo, Damini, Lucas Petri, Bronhara, Bruna, Cavalcanti, Alexandre B., Rosa, Regis G., Azevedo, Luciano C.P., Veiga, Viviane C., Machado, Flávia R, Ritt, Luiz Eduardo, Martins, Priscilla de Aquino, Alexander, John H., Avezum, Alvaro, and Berwanger, Otavio
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- 2021
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10. Mortality predictors in patients with suspected sepsis in the emergency department of a tertiary care hospital: a retrospective cohort study
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Bidart, João P. M., primary, Rosa, Regis G., additional, Bessel, Marina, additional, Pedrotti, Luana G., additional, and Goldani, Luciano Z., additional
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- 2024
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11. Predictors of early and long-term mortality after ICU discharge in critically ill COVID-19 patients: A prospective cohort study
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Santos, Mariana M. S., primary, Pereira, Isabel J., additional, Cuboia, Nelson, additional, Reis-Pardal, Joana, additional, Adrião, Diana, additional, Cardoso, Teresa, additional, Aragão, Irene, additional, Santos, Lurdes, additional, Sarmento, António, additional, Rosa, Regis G., additional, Granja, Cristina, additional, Teixeira, Cassiano, additional, and Azevedo, Luís, additional
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- 2023
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12. Early and Late Mortality Following Discharge From the ICU: A Multicenter Prospective Cohort Study*
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Rosa, Regis G., Falavigna, Maicon, Robinson, Caroline C., Sanchez, Evelin C., Kochhann, Renata, Schneider, Daniel, Sganzerla, Daniel, Dietrich, Camila, Barbosa, Mirceli G., de Souza, Denise, Rech, Gabriela S., dos Santos, Rosa da R., da Silva, Alice P., Santos, Mariana M., Dal Lago, Pedro, Sharshar, Tarek, Bozza, Fernando A., and Teixeira, Cassiano
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- 2020
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13. Rivaroxabana em Pacientes Ambulatoriais com COVID-19 Leve ou Moderada: Fundamentação e Desenho do Estudo CARE (CARE – Coalition COVID-19 Brazil VIII)
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Oliveira, Gustavo B. F., primary, Neves, Precil Diego M. M., additional, Oliveira, Haliton A., additional, Catarino, Daniela Ghidetti Mangas, additional, Alves, Lucas B. O., additional, Cavalcanti, Alexandre B., additional, Rosa, Regis G., additional, Veiga, Viviane C., additional, Azevedo, Luciano C.P., additional, Berwanger, Otávio, additional, Lopes, Renato D., additional, and Avezum, Álvaro, additional
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- 2023
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14. Rivaroxabana em Pacientes Ambulatoriais com COVID-19 Leve ou Moderada: Fundamentação e Desenho do Estudo CARE (CARE – Coalition COVID-19 Brazil VIII)
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Oliveira, Gustavo B. F., Neves, Precil Diego M. M., Oliveira, Haliton A., Catarino, Daniela Ghidetti Mangas, Alves, Lucas B. O., Cavalcanti, Alexandre B., Rosa, Regis G., Veiga, Viviane C., Azevedo, Luciano C.P., Berwanger, Otávio, Lopes, Renato D., and Avezum, Álvaro
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Rivaroxabana ,Treatment Outcome ,Outpatient Clinics, Hospital ,Rivaroxaban ,Trombose ,COVID-19 ,Thrombosis ,Ambulatório Hospitalar ,Resultado do Tratamento - Abstract
Resumo Fundamento Estudos anteriores revelaram alto risco de eventos tromboembólicos arteriais e venosos como consequência de danos virais diretos do SARS-CoV-2 em células endoteliais e um meio procoagulante devido ao aumento de biomarcadores como o D-dímero, fibrinogênio, fator VIII. Foram realizados ensaios controlados randomizados de terapias antitrombóticas em pacientes internados, no entanto, poucos estudos avaliaram o papel da tromboprofilaxia no ambiente ambulatorial. Objetivo Avaliar se a profilaxia antitrombótica com rivaroxabana reduz o risco de eventos trombóticos venosos ou arteriais, suporte ventilatório invasivo e morte em pacientes ambulatoriais com COVID-19. Métodos O estudo CARE é um ensaio randomizado, aberto, multicêntrico e controlado por rivaroxabana 10 mg uma vez por dia durante 14 dias ou tratamento local padrão isolado, para a prevenção de resultados adversos, registrado no Clinicaltrials.gov (NCT04757857). Os critérios de inclusão são adultos com infecção confirmada ou suspeita do SARS-CoV-2, com sintomas leves ou moderados, sem indicação de hospitalização, no prazo de 7 dias após o início dos sintomas e um fator de risco de complicação da COVID-19 (>65 anos, hipertensão, diabetes, asma, doença pulmonar obstrutiva crônica ou outras doenças pulmonares crônicas, tabagismo, imunossupressão ou obesidade). O desfecho primário composto inclui tromboembolismo venoso, necessidade de ventilação mecânica invasiva, eventos cardiovasculares agudos maiores e mortalidade no prazo de 30 dias após a randomização, sendo avaliado segundo o princípio da intenção de tratar. Todos os pacientes assinaram termo de consentimento. Foi estabelecido um nível de significância de 5% para todos os testes estatísticos. Resultados Os principais desfechos trombóticos e hemorrágicos, hospitalizações e mortes serão avaliados centralmente por um comitê de eventos clínicos independente, sob a condição cega para a alocação dos grupos de tratamento. Conclusão O estudo CARE fornecerá informação relevante e contemporânea sobre o possível papel da tromboprofilaxia em pacientes ambulatoriais com COVID-19. Abstract Background Previous studies have demonstrated a high risk of arterial and venous thromboembolic events as a consequence of direct viral damage to endothelial cells by SARS-CoV-2 and a procoagulant milieu due to increased biomarkers, such as D-dimer, fibrinogen, and factor VIII. Although randomized controlled trials of antithrombotic therapies have been conducted in hospitalized patients, few have evaluated the role of thromboprophylaxis in an outpatient setting. Objective To assess whether antithrombotic prophylaxis with rivaroxaban reduces the risk of venous or arterial thrombotic events, invasive ventilatory support, and death in COVID-19 outpatients. Methods The COVID Antithrombotic Rivaroxaban Evaluation (CARE) study, a multicenter, randomized, open-label, controlled trial of rivaroxaban 10 mg once daily for 14 days or local standard treatment alone to prevent adverse outcomes, is registered in clinicaltrials.gov (NCT04757857). The inclusion criteria are adults with confirmed or suspected SARS-CoV-2 infection and mild or moderate symptoms without indication for hospitalization, within 7 days of symptom onset, and 1 risk factor for COVID-19 complication (> 65 years, hypertension, diabetes mellitus, asthma, chronic obstructive pulmonary disease or other chronic lung diseases, smoking, immunosuppression, or obesity). The primary composite endpoint, which includes venous thromboembolism, invasive mechanical ventilation, major acute cardiovascular events, and mortality within 30 days of randomization, will be assessed according to the intention-to-treat principle. All patients will provide informed consent. A significance level of 5% will be used for all statistical tests. Results Major thrombotic and bleeding outcomes, hospitalizations, and deaths will be centrally adjudicated by an independent clinical events committee blinded to the assigned treatment groups. Conclusion The CARE study will provide relevant and contemporary information about the potential role of thromboprophylaxis in outpatients with COVID-19.
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- 2023
15. Rationale and Design of the COVID-19 Outpatient Prevention Evaluation (COPE - Coalition V) Randomized Clinical Trial: Hydroxychloroquine vs. Placebo in Non-Hospitalized Patients
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Oliveira Junior, Haliton Alves de, Ferri, Cleusa P., Boszczowski, Icaro, Oliveira, Gustavo B. F., Cavalcanti, Alexandre B., Rosa, Regis G., Lopes, Renato D., Azevedo, Luciano C. P., Veiga, Viviane C., Berwanger, Otavio, and Avezum, Álvaro
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Hidroxicloroquina ,Ensaio Clínico Controlado Aleatório ,SARS-CoV-2 ,Randomized Controlled Trial ,COVID-19 ,Hydroxychloroquine - Abstract
Resumo Fundamento Apesar da necessidade de opções terapêuticas específicas para a doença do coronavírus 2019 (covid-19), ainda não há evidências da eficácia de tratamentos específicos no contexto ambulatorial. Há poucos estudos randomizados que avaliam a hidroxicloroquina (HCQ) em pacientes não hospitalizados. Esses estudos não indicaram benefício com o uso da HCQ; no entanto, avaliaram desfechos primários diferentes e apresentaram vieses importantes na avaliação dos desfechos. Objetivo Investigar se a HCQ possui o potencial de prevenir hospitalizações por covid-19 quando comparada ao placebo correspondente. Métodos O estudo COVID-19 Outpatient Prevention Evaluation (COPE) é um ensaio clínico randomizado, pragmático, duplo-cego, multicêntrico e controlado por placebo que avalia o uso da HCQ (800 mg no dia 1 e 400 mg do dia 2 ao dia 7) ou placebo correspondente na prevenção de hospitalizações por covid-19 em casos precoces confirmados ou suspeitos de pacientes não hospitalizados. Os critérios de inclusão são adultos (≥ 18 anos) que procuraram atendimento médico com sintomas leves de covid-19, com randomização ≤ 7 dias após o início dos sintomas, sem indicação de hospitalização na triagem do estudo e com pelo menos um fator de risco para complicações (> 65 anos, hipertensão, diabetes melito, asma, doença pulmonar obstrutiva crônica ou outras doenças pulmonares crônicas, tabagismo, imunossupressão ou obesidade). Todos os testes de hipótese serão bilaterais. Um valor de p < 0,05 será considerado estatisticamente significativo em todas as análises. Clinicaltrials.gov: NCT04466540. Resultados Os desfechos clínicos serão avaliados centralmente por um comitê de eventos clínicos independente cegado para a alocação dos grupos de tratamento. O desfecho primário de eficácia será avaliado de acordo com o princípio da intenção de tratar. Conclusão Este estudo apresenta o potencial de responder de forma confiável a questão científica do uso da HCQ em pacientes ambulatoriais com covid-19. Do nosso conhecimento, este é o maior estudo avaliando o uso de HCQ em indivíduos com covid-19 não hospitalizados. Abstract Background Despite the need for targeting specific therapeutic options for coronavirus disease 2019 (COVID-19), there has been no evidence of effectiveness of any specific treatment for the outpatient clinical setting. There are few randomized studies evaluating hydroxychloroquine (HCQ) in non-hospitalized patients. These studies indicate no benefit from the use of HCQ, but they assessed different primary outcomes and presented important biases for outcome evaluation. Objective To evaluate if HCQ may prevent hospitalization due to COVID-19 compared to a matching placebo. Methods The COVID-19 Outpatient Prevention Evaluation (COPE) study is a pragmatic, randomized, double-blind, placebo-controlled clinical trial evaluating the use of HCQ (800 mg on day 1 and 400 mg from day 2 to day 7) or matching placebo for the prevention of hospitalization due to COVID-19 in early non-hospitalized confirmed or suspected cases. Inclusion criteria are adults (≥ 18 years) seeking medical care with mild symptoms of COVID-19, with randomization ≤ 7 days after symptom onset, without indication of hospitalization at study screening, and with at least one risk factor for complication (> 65 years; hypertension; diabetes mellitus; asthma; chronic obstructive pulmonary disease or other chronic lung diseases; smoking; immunosuppression; or obesity). All hypothesis tests will be two-sided. A p-value < 0.05 will be considered statistically significant in all analyses. Clinicaltrials.gov: NCT04466540. Results Clinical outcomes will be centrally adjudicated by an independent clinical event committee blinded to the assigned treatment groups. The primary efficacy endpoint will be assessed following the intention-to-treat principle. Conclusion This study has the potential to reliably answer the scientific question of HCQ use in outpatients with COVID-19. To our knowledge, this is the largest trial evaluating HCQ in non-hospitalized individuals with COVID-19.
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- 2022
16. Justificativa e Desenho do Ensaio Clínico Randomizado COVID-19 Outpatient Prevention Evaluation (COPE - Coalition V): Hidroxicloroquina vs. Placebo em Pacientes Não Hospitalizados
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Oliveira, Haliton Alves de, primary, Ferri, Cleusa P., additional, Boszczowski, Icaro, additional, Oliveira, Gustavo B. F., additional, Cavalcanti, Alexandre B., additional, Rosa, Regis G., additional, Lopes, Renato D., additional, Azevedo, Luciano C. P., additional, Veiga, Viviane C., additional, Berwanger, Otavio, additional, and Avezum, Álvaro, additional
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- 2022
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17. Convalescent plasma for COVID-19 in hospitalised patients: an open-label, randomised clinical trial
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Sekine, Leo, primary, Arns, Beatriz, additional, Fabro, Bruna R., additional, Cipolatt, Murillo M., additional, Machado, Rafael R.G., additional, Durigon, Edison L., additional, Parolo, Edino, additional, Pellegrini, José Augusto S., additional, Viana, Marina V., additional, Schwarz, Patrícia, additional, Lisboa, Thiago C., additional, Dora, José Miguel S., additional, Portich, Julia P., additional, Paz, Alessandra A., additional, Silla, Lucia, additional, Balsan, Almeri M., additional, Schirmer, Felipe da-Silva, additional, Franz, Juliana P.M., additional, da-Silveira, Luciana M., additional, Breunig, Raquel C., additional, Petersen, Viviana, additional, Sosnoski, Monalisa, additional, Mesquita, Nanci F., additional, Volpato, Fabiana Caroline Z., additional, Sganzerla, Daniel, additional, Falavigna, Maicon, additional, Rosa, Regis G., additional, and Zavascki, Alexandre P., additional
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- 2021
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18. Therapeutic versus prophylactic anticoagulation for patients admitted to hospital with COVID-19 and elevated D-dimer concentration (ACTION): an open-label, multicentre, randomised, controlled trial
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Lopes, Renato D, primary, de Barros e Silva, Pedro Gabriel Melo, additional, Furtado, Remo H M, additional, Macedo, Ariane Vieira Scarlatelli, additional, Bronhara, Bruna, additional, Damiani, Lucas Petri, additional, Barbosa, Lilian Mazza, additional, de Aveiro Morata, Júlia, additional, Ramacciotti, Eduardo, additional, de Aquino Martins, Priscilla, additional, de Oliveira, Aryadne Lyrio, additional, Nunes, Vinicius Santana, additional, Ritt, Luiz Eduardo Fonteles, additional, Rocha, Ana Thereza, additional, Tramujas, Lucas, additional, Santos, Sueli V, additional, Diaz, Dario Rafael Abregu, additional, Viana, Lorena Souza, additional, Melro, Lívia Maria Garcia, additional, de Alcântara Chaud, Mariana Silveira, additional, Figueiredo, Estêvão Lanna, additional, Neuenschwander, Fernando Carvalho, additional, Dracoulakis, Marianna Deway Andrade, additional, Lima, Rodolfo Godinho Souza Dourado, additional, de Souza Dantas, Vicente Cés, additional, Fernandes, Anne Cristine Silva, additional, Gebara, Otávio Celso Eluf, additional, Hernandes, Mauro Esteves, additional, Queiroz, Diego Aparecido Rios, additional, Veiga, Viviane C, additional, Canesin, Manoel Fernandes, additional, de Faria, Leonardo Meira, additional, Feitosa-Filho, Gilson Soares, additional, Gazzana, Marcelo Basso, additional, Liporace, Idelzuíta Leandro, additional, de Oliveira Twardowsky, Aline, additional, Maia, Lilia Nigro, additional, Machado, Flávia Ribeiro, additional, de Matos Soeiro, Alexandre, additional, Conceição-Souza, Germano Emílio, additional, Armaganijan, Luciana, additional, Guimarães, Patrícia O, additional, Rosa, Regis G, additional, Azevedo, Luciano C P, additional, Alexander, John H, additional, Avezum, Alvaro, additional, Cavalcanti, Alexandre B, additional, and Berwanger, Otavio, additional
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- 2021
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19. The Burden of Mental Illness Among Survivors of Critical Care—Risk Factors and Impact on Quality of Life: A Multicenter Prospective Cohort Study
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Teixeira, Cassiano, Rosa, Regis G., Sganzerla, Daniel, Sanchez, Évelin Carneiro, Robinson, Caroline Cabral, Dietrich, Camila, Kochhann, Renata, de Souza, Denise, Rech, Gabriela Soares, da R. dos Santos, Rosa, Schneider, Daniel, Boldo, Rodrigo, Sharshar, Tarek, Bozza, Fernando Augusto, Falavigna, Maicon, Friedman, Gilberto, Universidade Federal do Rio Grande do Sul [Porto Alegre] (UFRGS), Hospital Moinhos de Vento de Porto Alegre, Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), Hôpital Raymond Poincaré [AP-HP], D'Or Institute for Research and Education [Rio de Janeiro], Ministério da Saúde, and FUNDING/SUPPORT: The present research was supported by the Brazilian Ministry of Health through the Program of Institutional Development of the Brazilian Unified Health System.
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critical care ,[SDV]Life Sciences [q-bio] ,depression ,risk factors ,stress disorder ,posttraumatic ,anxiety ,critical care outcomes ,humanities ,mental disorders - Abstract
International audience; Background: Survivors of critical care may demonstrate mental health disorders in the months after discharge. Research Question: What are risk factors for mental health disorders after ICU discharge and is there an association between the burden of mental illness and health-related quality of life (HRQoL)? Study Design and Methods: Multicenter prospective cohort study that included 579 adult ICU survivors with an ICU stay of > 72 h in 10 ICUs. Results: The outcomes were anxiety and depression assessed by the Hospital Anxiety and Depression Scale, posttraumatic stress disorder (PTSD) assessed by the Impact Event Scale 6, and HRQoL assessed by the Short Form 12 version 2. The 6-month prevalences of any mental health disorder were 36.2% (the prevalences of anxiety, depression, and PTSD were 24.2%, 20.9%, and 15.4%, respectively). ICU survivors with mental health disorders showed worse HRQoL scores in both physical and mental dimensions than those without. The higher the number of psychiatric syndromes manifested, the worse the mental dimension of HRQoL. Age of < 65 years (P = .009), history of depression (P = .009), anxiety (P = .003) and depression (P = .02) symptoms at ICU discharge, physical dependence (P = .01), and decreased physical functional status (P = .04) at 6 months were associated with anxiety. History of depression (P = .001), depression symptoms at ICU discharge (P < .001), and decreased physical functional status at 6 months (P = .01) were associated with depression. Depression symptoms at ICU discharge (P = .01), physical dependence (P = .01), and decreased physical functional status (P = .02) at 6 months were associated with PTSD. Interpretation: The network of potential risk factors for mental illness among patients discharged from an ICU is complex and involves multiple factors (age, premorbid mental health, acute emotional stress, and physical impairment after ICU stay). The negative impact of the burden of mental illness on HRQoL among critical care survivors is of concern.
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- 2021
20. Association between administration of IL-6 antagonists and mortality among patients hospitalized for COVID-19 : a meta-analysis
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The WHO Rapid Evidence Appraisal for COVID-19 Therapies (REACT) Working Group, [missing], Domingo, Pere, Mur, Isabel, Mateo, Gracia María, Gutierrez, Maria del Mar, Pomar, Virginia, de Benito, Natividad, Corbacho, Noemí, Herrera, Silvia, Millan, Lucia, Muñoz, Jessica, Malouf, Jorge, Molas, Maria Ema, Asensi, Victor, Horcajada, Juan Pablo, Estrada, Vicente, Gutierrez, Felix, Torres, Ferran, Perez-Molina, Jose A, Fortun, Jesús, Villar, Luisa M, Hohenthal, Ulla, Marttila, Harri, Vuorinen, Tytti, Nordberg, Marika, Valtonen, Mika, Frigault, Matthew J, Mansour, Michael K, Patel, Naomi J, Fernandes, Ana, Harvey, Liam, Foulkes, Andrea S, Healy, Brian C, Shah, Ruta, Bensaci, Ana Maria, Woolley, Ann E., Nikiforow, Sarah, Lin, Nina, Sagar, Manish, Shrager, Harry, Huckins, David S., Axelrod, Matthew, Pincus, Michael D, Fleisher, Jorge, Lampa, Jon, Nowak, Piotr, Vesterbacka, Jan C., Rasmuson, Johan, Skorup, Paul, Janols, Helena, Niward, Katarina F, Chatzidionysiou, Katerina, Asgeirsson, Hilmir, Parke, Åsa, Blennow, Ola, Svensson, Anna-Karin, Aleman, Soo, Sönnerborg, Anders, Henter, Jan-Inge, Horne, Anna Carin, Al-Beidh, Farah, Angus, Derek, Annane, Djillali, Arabi, Yaseen, Beane, Abigail, Berry, Scott, Bhimani, Zahra, Bonten, Marc, Bradbury, Charlotte, Brunkhorst, Frank, Buxton, Meredith, Cheng, Allen, Cove, Matt, De Jong, Menno, Derde, Lennie, Estcourt, Lise, Goossens, Herman, Gordon, Anthony, Green, Cameron, Haniffa, Rashan, Ichihara, Nao, Lamontagne, Francois, Lawler, Patrick, Litton, Ed, Marshall, John, McArthur, Colin, McAuley, Daniel, McGuinness, Shay, McVerry, Bryan, Montgommery, Stephanie, Mouncey, Paul, Murthy, Srinivas, Nichol, Alistair, Parke, Rachael, Parker, Jane, Reyes, Felipe, Rowan, Kathryn, Saito, Hiroki, Santos, Marlene, Seymour, Chris, Shankar-Hari, Manu, Turgeon, Alexis, Turner, Anne, van Bentum-Puijk, Wilma, van de Veerdonk, Frank, Webb, Steve, Zarychanski, Ryan, Baillie, J Kenneth, Beasley, Richard, Cooper, Nichola, Fowler, Robert, Galea, James, Hills, Thomas, King, Andrew, Morpeth, Susan, Netea, Mihai, Ogungbenro, Kayode, Pettila, Ville, Tong, Steve, Uyeki, Tim, Youngstein, Taryn, Higgins, Alisa, Lorenzi, Elizabeth, Berry, Lindsay, Salama, Carlos, Rosas, Ivan O., Ruiz-Antorán, Belén, Muñez Rubio, Elena, Ramos Martínez, Antonio, Campos Esteban, José, Avendaño Solá, Cristina, Pizov, Reuven, Sanz Sanz, Jesus, Abad-Santos, Francisco, Bautista-Hernández, Azucena, García-Fraile, Lucio, Barrios, Ana, Gutiérrez Liarte, Ángela, Alonso Pérez, Tamara, Rodríguez-García, Sebastian C, Mejía-Abril, Gina, Prieto, Jose Carlos, Leon, Rafael, VEIGA, VIVIANE C., SCHEINBERG, PHILLIP, FARIAS, DANIELLE L.C., PRATS, JOÃO G., CAVALCANTI, ALEXANDRE B., MACHADO, FLAVIA R., ROSA, REGIS G., BERWANGER, OTÁVIO, AZEVEDO, LUCIANO C.P., LOPES, RENATO D., DOURADO, LETICIA K., CASTRO, CLAUDIO G., ZAMPIERI, FERNANDO G., AVEZUM, ALVARO, LISBOA, THIAGO C., ROJAS, SALOMÓN S.O., COELHO, JULIANA C., LEITE, RODRIGO T., CARVALHO, JULIO CESAR, ANDRADE, LUIS E.C., SANDES, ALEX R., PINTÃO, MARIA CAROLINA T., SANTOS, SUELI V., ALMEIDA, THIAGO M.L., COSTA, ANDRÉ N., GEBARA, OTAVIO C.E., FREITAS, FLAVIO G.R., PACHECO, EDUARDO S., MACHADO, DAVID J.B., MARTIN, JOSIANE, CONCEIÇÃO, FABIO G., SIQUEIRA, SUELLEN R.R., DAMIANI, LUCAS P., ISHIHARA, LUCIANA M., SCHNEIDER, DANIEL, DE SOUZA, DENISE, Hermine, Olivier, Mariette, Xavier, Tharaux, Pierre Louis, Resche Rigon, Matthieu, Porcher, Raphael, Ravaud, Philippe, Azoulay, Elie, Cadranel, Jacques, Emmerich, Joseph, Fartoukh, Muriel, Guidet, Bertrand, Humbert, Marc, Lacombe, Karine, Mahevas, Matthieu, Pene, Frédéric, Pourchet-Martinez, Valérie, Schlemmer, Frédéric, Tibi, Annick, Yazdanpanah, Yazdan, Dougados, Maxime, Bureau, Serge, Horby, Peter W, Landray, Martin J, Baillie, Kenneth J, Buch, Maya H, Chappell, Lucy C, Day, Jeremy N, Faust, Saul N, Haynes, Richard, Jaki, Thomas, Jeffery, Katie, Juszczak, Edmund, Lim, Wei Shen, Mafham, Marion, Montgomery, Alan, Mumford, Andrew, Thwaites, Guy, Kamarulzaman, Adeeba, Syed Omar, Sharifah Faridah, Ponnampalavanar, Sasheela, Raja Azwa, Raja Iskandar Syah, Wong, Pui Li, Kukreja, Anjanna, Ong, Hang Cheng, Sulaiman, Helmi, Basri, Sazali, Ng, Rong Xiang, Megat Johari, Bushra, Rajasuriar, Reena, Chong, Meng Li, Neelamegam, Malinee, Syed Mansor, Syed Mukhtar, Zulhaimi, Nurul Syuhada, Lee, Cheng Siang, Altice, Frederick, Price, Christina, Malinis, Maricar, Hasan, Mohd Shahnaz, Wong, Chee Kuan, Chidambaram, Suresh, Misnan, Nor Arisah, Mohd Thabit, Alif Adlan, Sim, Benedict, Bidin, Farah Nadiah, Mohd Abd Rahim, Mohd Abd Hafiz, Saravanamuttu, Sujana, Tuang, Wei Xuan, Mohamed Gani, Yasmin, Thangavelu, Suvintheran, Tay, Kim Heng, Ibrahim, Nur Munirah, Halid, Luqman Alhakim, Tan, Kok Tong, Mukri, Mohd Noor Azreet, Arip, Masita, Koh, Hui Moon, Syed Badaruddin, Syarifah Nurul Ain, Raja Sureja, Letchumi, Chun, Geok Ying, TORRE-CISNEROS, JULIAN, MERCHANTE, NICOLAS, LEON, RAFAEL, CARCEL, SHEILA, GARRIDO, JOSE CARLOS, Galun, Eitan, Soriano, Alex, Martínez, José Antonio, Castán, Clara, Paredes, Roger, Dalmau, David, Carbonell, Cristina, Espinosa, Gerard, Castro, Pedro, Muñóz, José, Almuedo, Alex, Prieto, Sergio, Pacheco, Iván, Ratain, Mark, Pisano, Jennifer, Strek, Mary, Adegunsoye, Ayodeji, Karrison, Theodore, Declercq, Jozefien, Van Damme, Karel, De Leeuw, Elisabeth, Bosteels, Cedric, Maes, Bastiaan, Vale, Claire L., Godolphin, Peter J., Fisher, David, Higgins, Julian P. T., Spiga, Francesca, Savovic, Jelena, Tierney, Jayne, Baron, Gabriel, Benbenishty, Julie S., Berry, Lindsay R., Broman, Niklas, Cavalcanti, Alexandre Biasi, Colman, Roos, De Buyser, Stefanie, Derde, Lennie P. G., Omar, Sharifah Faridah, Fernandez-Cruz, Ana, Feuth, Thijs, Garcia, Felipe, Garcia-Vicuna, Rosario, Gonzalez-Alvaro, Isidoro, Gordon, Anthony C., Horby, Peter W., Horick, Nora K., Kumar, Kuldeep, Lambrecht, Bart, Landray, Martin J., Leal, Lorna, Lederer, David J., Merchante, Nicolas, Mohan, Shalini V., Nivens, Michael C., Oksi, Jarmo, Perez-Molina, Jose A., Postma, Simone, Ramanan, Athimalaipet V., Reid, Pankti D., Rutgers, Abraham, Sancho-Lopez, Aranzazu, Seto, Todd B., Sivapalasingam, Sumathi, Soin, Arvinder Singh, Staplin, Natalie, Stone, John H., Strohbehn, Garth W., Sunden-Cullberg, Jonas, Torre-Cisneros, Julian, Tsai, Larry W., van Hoogstraten, Hubert, van Meerten, Tom, Veiga, Viviane Cordeiro, Westerweel, Peter E., Diaz, Janet V., Marshall, John C., Sterne, Jonathan A. C., Translational Immunology Groningen (TRIGR), Stem Cell Aging Leukemia and Lymphoma (SALL), World Health Organization, and Group, WHO Rapid Evidence Appraisal for COVID-19 Therapies (REACT) Working
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Male ,medicine.medical_specialty ,Randomization ,Secondary infection ,Placebo ,Antibodies, Monoclonal, Humanized ,Internal medicine ,Cause of Death ,Medicine and Health Sciences ,Medicine ,Humans ,Prospective Studies ,Prospective cohort study ,Glucocorticoids ,METAANALYSIS ,Cause of death ,Aged ,Randomized Controlled Trials as Topic ,business.industry ,Coinfection ,Interleukin-6 ,COVID-19 ,Odds ratio ,General Medicine ,Middle Aged ,Respiration, Artificial ,COVID-19 Drug Treatment ,Clinical trial ,Hospitalization ,Meta-analysis ,Disease Progression ,Drug Therapy, Combination ,Female ,business - Abstract
[Importance] Clinical trials assessing the efficacy of IL-6 antagonists in patients hospitalized for COVID-19 have variously reported benefit, no effect, and harm., [Objective] To estimate the association between administration of IL-6 antagonists compared with usual care or placebo and 28-day all-cause mortality and other outcomes., [Data Sources] Trials were identified through systematic searches of electronic databases between October 2020 and January 2021. Searches were not restricted by trial status or language. Additional trials were identified through contact with experts., [Study Selection] Eligible trials randomly assigned patients hospitalized for COVID-19 to a group in whom IL-6 antagonists were administered and to a group in whom neither IL-6 antagonists nor any other immunomodulators except corticosteroids were administered. Among 72 potentially eligible trials, 27 (37.5%) met study selection criteria., [Data Extraction and Synthesis] In this prospective meta-analysis, risk of bias was assessed using the Cochrane Risk of Bias Assessment Tool. Inconsistency among trial results was assessed using the I2 statistic. The primary analysis was an inverse variance–weighted fixed-effects meta-analysis of odds ratios (ORs) for 28-day all-cause mortality., [Main Outcomes and Measures] The primary outcome measure was all-cause mortality at 28 days after randomization. There were 9 secondary outcomes including progression to invasive mechanical ventilation or death and risk of secondary infection by 28 days., [Results] A total of 10 930 patients (median age, 61 years [range of medians, 52-68 years]; 3560 [33%] were women) participating in 27 trials were included. By 28 days, there were 1407 deaths among 6449 patients randomized to IL-6 antagonists and 1158 deaths among 4481 patients randomized to usual care or placebo (summary OR, 0.86 [95% CI, 0.79-0.95]; P = .003 based on a fixed-effects meta-analysis). This corresponds to an absolute mortality risk of 22% for IL-6 antagonists compared with an assumed mortality risk of 25% for usual care or placebo. The corresponding summary ORs were 0.83 (95% CI, 0.74-0.92; P, [Conclusions and Relevance] In this prospective meta-analysis of clinical trials of patients hospitalized for COVID-19, administration of IL-6 antagonists, compared with usual care or placebo, was associated with lower 28-day all-cause mortality., [Trial Registration] PROSPERO Identifier: CRD42021230155., Funding for administrative and communications support was provided by the World Health Organization.
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- 2021
21. Risk factors for multidrug-resistant bacteremia in hospitalized cancer patients with febrile neutropenia: A cohort study
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Rosa, Regis G., Goldani, Luciano Z., and dos Santos, Rodrigo P.
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- 2014
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22. Effect of Dexamethasone on Days Alive and Ventilator-Free in Patients With Moderate or Severe Acute Respiratory Distress Syndrome and COVID-19
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Tomazini, Bruno M., Maia, Israel S., Cavalcanti, Alexandre B., Berwanger, Otavio, Rosa, Regis G., Veiga, Viviane C., Avezum, Alvaro, Lopes, Renato D., Bueno, Flavia R., Silva, Maria Vitoria A. O., Baldassare, Franca P., Costa, Eduardo L. V., Moura, Ricardo A. B., Honorato, Michele O., Costa, Andre N., Damiani, Lucas P., Lisboa, Thiago, Kawano-Dourado, Letícia, Zampieri, Fernando G., Olivato, Guilherme B., Righy, Cassia, Amendola, Cristina P., Roepke, Roberta M. L., Freitas, Daniela H. M., Forte, Daniel N., Freitas, Flávio G. R., Fernandes, Caio C. F., Melro, Livia M. G., Junior, Gedealvares F. S., Morais, Douglas Costa, Zung, Stevin, Machado, Flávia R., and Azevedo, Luciano C. P.
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General Medicine - Published
- 2020
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23. Effect of tocilizumab on clinical outcomes at 15 days in patients with severe or critical coronavirus disease 2019: randomised controlled trial
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Veiga, Viviane C, primary, Prats, João A G G, additional, Farias, Danielle L C, additional, Rosa, Regis G, additional, Dourado, Leticia K, additional, Zampieri, Fernando G, additional, Machado, Flávia R, additional, Lopes, Renato D, additional, Berwanger, Otavio, additional, Azevedo, Luciano C P, additional, Avezum, Álvaro, additional, Lisboa, Thiago C, additional, Rojas, Salomón S O, additional, Coelho, Juliana C, additional, Leite, Rodrigo T, additional, Carvalho, Júlio C, additional, Andrade, Luis E C, additional, Sandes, Alex F, additional, Pintão, Maria C T, additional, Castro, Claudio G, additional, Santos, Sueli V, additional, de Almeida, Thiago M L, additional, Costa, André N, additional, Gebara, Otávio C E, additional, de Freitas, Flávio G Rezende, additional, Pacheco, Eduardo S, additional, Machado, David J B, additional, Martin, Josiane, additional, Conceição, Fábio G, additional, Siqueira, Suellen R R, additional, Damiani, Lucas P, additional, Ishihara, Luciana M, additional, Schneider, Daniel, additional, de Souza, Denise, additional, Cavalcanti, Alexandre B, additional, and Scheinberg, Phillip, additional
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- 2021
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24. Hydroxychloroquine with or without Azithromycin in Mild-to-Moderate Covid-19
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Cavalcanti, Alexandre B., primary, Zampieri, Fernando G., additional, Rosa, Regis G., additional, Azevedo, Luciano C.P., additional, Veiga, Viviane C., additional, Avezum, Alvaro, additional, Damiani, Lucas P., additional, Marcadenti, Aline, additional, Kawano-Dourado, Letícia, additional, Lisboa, Thiago, additional, Junqueira, Debora L. M., additional, de Barros e Silva, Pedro G.M., additional, Tramujas, Lucas, additional, Abreu-Silva, Erlon O., additional, Laranjeira, Ligia N., additional, Soares, Aline T., additional, Echenique, Leandro S., additional, Pereira, Adriano J., additional, Freitas, Flávio G.R., additional, Gebara, Otávio C.E., additional, Dantas, Vicente C.S., additional, Furtado, Remo H.M., additional, Milan, Eveline P., additional, Golin, Nicole A., additional, Cardoso, Fábio F., additional, Maia, Israel S., additional, Hoffmann Filho, Conrado R., additional, Kormann, Adrian P.M., additional, Amazonas, Roberto B., additional, Bocchi de Oliveira, Monalisa F., additional, Serpa-Neto, Ary, additional, Falavigna, Maicon, additional, Lopes, Renato D., additional, Machado, Flávia R., additional, and Berwanger, Otavio, additional
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- 2020
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25. Azithromycin in addition to standard of care versus standard of care alone in the treatment of patients admitted to the hospital with severe COVID-19 in Brazil (COALITION II): a randomised clinical trial
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Furtado, Remo H M, primary, Berwanger, Otavio, additional, Fonseca, Henrique A, additional, Corrêa, Thiago D, additional, Ferraz, Leonardo R, additional, Lapa, Maura G, additional, Zampieri, Fernando G, additional, Veiga, Viviane C, additional, Azevedo, Luciano C P, additional, Rosa, Regis G, additional, Lopes, Renato D, additional, Avezum, Alvaro, additional, Manoel, Airton L O, additional, Piza, Felipe M T, additional, Martins, Priscilla A, additional, Lisboa, Thiago C, additional, Pereira, Adriano J, additional, Olivato, Guilherme B, additional, Dantas, Vicente C S, additional, Milan, Eveline P, additional, Gebara, Otavio C E, additional, Amazonas, Roberto B, additional, Oliveira, Monalisa B, additional, Soares, Ronaldo V P, additional, Moia, Diogo D F, additional, Piano, Luciana P A, additional, Castilho, Kleber, additional, Momesso, Roberta G R A P, additional, Schettino, Guilherme P P, additional, Rizzo, Luiz Vicente, additional, Neto, Ary Serpa, additional, Machado, Flávia R, additional, and Cavalcanti, Alexandre B, additional
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- 2020
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26. Cardiovascular risk and bipolar disorder: factors associated with a positive coronary calcium score in patients with bipolar disorder type 1
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Wageck, Aline R., primary, Torres, Felipe S., additional, Gama, Clarissa S., additional, Martins, Dayane S., additional, Scotton, Ellen, additional, Reckziegel, Ramiro, additional, Costanzi, Monise, additional, Rosa, Regis G., additional, Kapczinski, Flávio, additional, and Kunz, Maurício, additional
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- 2017
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27. Association between Accessory Gene Regulator Polymorphism and Mortality among Critically Ill Patients Receiving Vancomycin for Nosocomial MRSA Bacteremia: A Cohort Study
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Cechinel, Angélica, primary, Machado, Denise P., additional, Turra, Eduardo, additional, Pereira, Dariane, additional, dos Santos, Rodrigo P., additional, Rosa, Regis G., additional, and Goldani, Luciano Z., additional
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- 2016
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28. Managing clozapine-induced neutropenic fever: A case report
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Rosa, Regis G., primary, Rosa, Maria D., primary, and Barros, Alcina J. S., primary
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- 2015
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29. Factors Associated with Hospital Length of Stay among Cancer Patients with Febrile Neutropenia
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Rosa, Regis G., primary and Goldani, Luciano Z., additional
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- 2014
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30. Mood disorder as a manifestation of primary hypoparathyroidism: a case report
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Rosa, Regis G, primary, Barros, Alcina JS, additional, de Lima, Antonio RB, additional, Lorenzi, William, additional, Da Rosa, Rafael R, additional, Zambonato, Karine D, additional, and Alves, Gustavo V, additional
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- 2014
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31. Comparison of anti-anaerobic antimicrobial strategies in cancer patients with febrile neutropenia and gastrointestinal symptoms
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Rosa, Regis G, primary, dos Santos, Rodrigo P, additional, and Goldani, Luciano Z, additional
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- 2014
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32. Cohort Study of the Impact of Time to Antibiotic Administration on Mortality in Patients with Febrile Neutropenia
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Rosa, Regis G., primary and Goldani, Luciano Z., additional
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- 2014
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33. Association between adherence to an antimicrobial stewardship program and mortality among hospitalised cancer patients with febrile neutropaenia: a prospective cohort study
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Rosa, Regis G, primary, Goldani, Luciano Z, additional, and dos Santos, Rodrigo P, additional
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- 2014
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34. Vancomycin-ResistantEnterococcus faeciumBacteremia in a Tertiary Care Hospital: Epidemiology, Antimicrobial Susceptibility, and Outcome
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Rosa, Regis G., primary, Schwarzbold, Alexandre V., additional, Santos, Rodrigo P. dos, additional, Turra, Eduardo E., additional, Machado, Denise P., additional, and Goldani, Luciano Z., additional
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- 2014
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35. Mortality Related to Coagulase-Negative Staphylococcal Bacteremia in Febrile Neutropenia: A Cohort Study
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Rosa, Regis G, primary, dos Santos, Rodrigo P, additional, and Goldani, Luciano Z, additional
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- 2014
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36. Sporotrichosis in Renal Transplant Patients
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Gewehr, Paulo, primary, Jung, Bruno, additional, Aquino, Valerio, additional, Manfro, Roberto C, additional, Spuldaro, Fábio, additional, Rosa, Regis G, additional, and Goldani, Luciano Z, additional
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- 2013
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37. Vancomycin-Resistant Enterococcus faecium Bacteremia in a Tertiary Care Hospital: Epidemiology, Antimicrobial Susceptibility, and Outcome.
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Rosa, Regis G., Schwarzbold, Alexandre V., Santos, Rodrigo P. dos, Turra, Eduardo E., Machado, Denise P., and Goldani, Luciano Z.
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Vancomycin-resistant Enterococcus faecium (VREF) has emerged as a relevant multidrug-resistant pathogen and potentially lethal etiology of health care associated infections worldwide. The objective of this retrospective cohort study was to assess factors associated with mortality in patients with VREF bacteremia in a major tertiary referral hospital in Southern Brazil. All documented cases of bacteremia identified between May 2010 and July 2012 were evaluated. Cox regression was performed to determine whether the characteristics related to the host or antimicrobial treatment were associated with the all-cause 30-day mortality. In total, 35 patients with documented VREF bacteremia were identified during the study period. The median APACHE-II score of the study population was 26 (interquartile range: 10).The overall 30-day mortality was 65.7%. All VREF isolates were sensitive to linezolid, daptomycin, and quinupristin-dalfopristin. Line zolid was the only antimicrobial agent with in vitro activity against VREF that was administered to the cohort. After multivariate analysis, linezolid treatment (HR, 0.08; 95% CI, 0.02-0.27) and presence of acute kidney injury at the onset of bacteremia (HR, 4.01; 95% CI, 1.62-9.94) were independently associated with mortality. Presentation with acute kidney injury and lack of treatment with an effective antibiotic poses risk for mortality in patients with VREF bacteremia. [ABSTRACT FROM AUTHOR]
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- 2014
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38. Cardiovascular risk and bipolar disorder: factors associated with a positive coronary calcium score in patients with bipolar disorder type 1.
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Wageck, Aline R., Torres, Felipe S., Gama, Clarissa S., Martins, Dayane S., Scotton, Ellen, Reckziegel, Ramiro, Costanzi, Monise, Rosa, Regis G., Kapczinski, Flávio, and Kunz, Maurício
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BIPOLAR disorder , *CARDIOVASCULAR diseases risk factors , *CALCIUM , *COMPUTED tomography , *POISSON regression , *RISK assessment - Abstract
Objective: Cardiovascular disease is the leading cause of death in patients with bipolar disorder. The aim of this study was to evaluate the factors associated with positive coronary calcium score (CCS) in individuals with bipolar disorder type 1. Methods: Patients from the Bipolar Disorder Program at Hospital de Clínicas de Porto Alegre, Brazil, underwent computed tomography scanning for calcium score measurement. Clinical and sociodemographic variables were compared between patients according to their CCS status: negative (CCS = 0) or positive (CCS > 0). Poisson regression analysis was used to examine the association of CCS with number of psychiatric hospitalizations. Results: Out of 41 patients evaluated, only 10 had a positive CCS. Individuals in the CCS-positive group were older (55.2±4.2 vs. 43.1±10.0 years; p = 0.001) and had more psychiatric hospitalizations (4.7±3.0 vs. 2.6±2.5; p = 0.04) when compared with CCS-negative subjects. The number of previous psychiatric hospitalizations correlated positively with CCS (p < 0.001). Conclusion: Age and number of psychiatric hospitalizations were significantly associated with higher CCS, which might be a potential method for diagnosis and stratification of cardiovascular disease in bipolar patients. There is a need for increased awareness of risk assessment in this population. [ABSTRACT FROM AUTHOR]
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- 2018
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39. Effect of Tele-ICU on Clinical Outcomes of Critically Ill Patients: The TELESCOPE Randomized Clinical Trial.
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Pereira AJ, Noritomi DT, Dos Santos MC, Corrêa TD, Ferraz LJR, Schettino GPP, Cordioli E, Morbeck RA, Morais LC, Salluh JIF, Azevedo LCP, Biondi RS, Rosa RG, Cavalcanti AB, Berwanger O, Serpa Neto A, and Ranzani OT
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Importance: Despite its implementation in several countries, there has not been a randomized clinical trial to assess whether telemedicine in intensive care units (ICUs) could improve clinical outcomes of critically ill patients., Objective: To determine whether an intervention comprising daily multidisciplinary rounds and monthly audit and feedback meetings performed by a remote board-certified intensivist reduces ICU length of stay (LOS) compared with usual care., Design, Setting, and Participants: A parallel cluster randomized clinical trial with a baseline period in 30 general ICUs in Brazil in which daily multidisciplinary rounds performed by board-certified intensivists were not routinely available. All consecutive adult patients (aged ≥18 years) admitted to the participating ICUs, excluding those admitted due to justice-related issues, were enrolled between June 1, 2019, and April 7, 2021, with last follow-up on July 6, 2021., Intervention: Remote daily multidisciplinary rounds led by a board-certified intensivist through telemedicine, monthly audit and feedback meetings for discussion of ICU performance indicators, and provision of evidence-based clinical protocols., Main Outcomes and Measures: The primary outcome was ICU LOS at the patient level. Secondary outcomes included ICU efficiency, in-hospital mortality, incidence of central line-associated bloodstream infections, ventilator-associated events, catheter-associated urinary tract infections, ventilator-free days at 28 days, patient-days receiving oral or enteral feeding, patient-days under light sedation, and rate of patients with oxygen saturation values under that of normoxemia, assessed using generalized linear mixed models., Results: Among 17 024 patients (1794 in the baseline period and 15 230 in the intervention period), the mean (SD) age was 61 (18) years, 44.7% were female, the median (IQR) Sequential Organ Failure Assessment score was 6 (2-9), and 45.5% were invasively mechanically ventilated at admission. The median (IQR) time under intervention was 20 (16-21) months. Mean (SD) ICU LOS, adjusted for baseline assessment, did not differ significantly between the tele-critical care and usual care groups (8.1 [10.0] and 7.1 [9.0] days; percentage change, 8.2% [95% CI, -5.4% to 23.8%]; P = .24). Results were similar in sensitivity analyses and prespecified subgroups. There were no statistically significant differences in any other secondary or exploratory outcomes., Conclusions and Relevance: Daily multidisciplinary rounds conducted by a board-certified intensivist through telemedicine did not reduce ICU LOS in critically ill adult patients., Trial Registration: ClinicalTrials.gov Identifier: NCT03920501.
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- 2024
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40. Rivaroxaban in Outpatients with Mild or Moderate COVID-19: Rationale and Design of the Study CARE (CARE - Coalition COVID-19 Brazil VIII).
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Oliveira GBF, Neves PDMM, Oliveira HA, Catarino DGM, Alves LBO, Cavalcanti AB, Rosa RG, Veiga VC, Azevedo LCP, Berwanger O, Lopes RD, and Avezum Á
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- Adult, Humans, SARS-CoV-2, Rivaroxaban, Outpatients, Anticoagulants, Brazil, Endothelial Cells, Fibrinolytic Agents, Treatment Outcome, Randomized Controlled Trials as Topic, COVID-19, Venous Thromboembolism, Thrombosis
- Abstract
Background: Previous studies have demonstrated a high risk of arterial and venous thromboembolic events as a consequence of direct viral damage to endothelial cells by SARS-CoV-2 and a procoagulant milieu due to increased biomarkers, such as D-dimer, fibrinogen, and factor VIII. Although randomized controlled trials of antithrombotic therapies have been conducted in hospitalized patients, few have evaluated the role of thromboprophylaxis in an outpatient setting., Objective: To assess whether antithrombotic prophylaxis with rivaroxaban reduces the risk of venous or arterial thrombotic events, invasive ventilatory support, and death in COVID-19 outpatients., Methods: The COVID Antithrombotic Rivaroxaban Evaluation (CARE) study, a multicenter, randomized, open-label, controlled trial of rivaroxaban 10 mg once daily for 14 days or local standard treatment alone to prevent adverse outcomes, is registered in clinicaltrials.gov (NCT04757857). The inclusion criteria are adults with confirmed or suspected SARS-CoV-2 infection and mild or moderate symptoms without indication for hospitalization, within 7 days of symptom onset, and 1 risk factor for COVID-19 complication (> 65 years, hypertension, diabetes mellitus, asthma, chronic obstructive pulmonary disease or other chronic lung diseases, smoking, immunosuppression, or obesity). The primary composite endpoint, which includes venous thromboembolism, invasive mechanical ventilation, major acute cardiovascular events, and mortality within 30 days of randomization, will be assessed according to the intention-to-treat principle. All patients will provide informed consent. A significance level of 5% will be used for all statistical tests., Results: Major thrombotic and bleeding outcomes, hospitalizations, and deaths will be centrally adjudicated by an independent clinical events committee blinded to the assigned treatment groups., Conclusion: The CARE study will provide relevant and contemporary information about the potential role of thromboprophylaxis in outpatients with COVID-19.
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- 2023
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41. Convalescent plasma for COVID-19 in hospitalised patients: an open-label, randomised clinical trial.
- Author
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Sekine L, Arns B, Fabro BR, Cipolatt MM, Machado RRG, Durigon EL, Parolo E, Pellegrini JAS, Viana MV, Schwarz P, Lisboa TC, Dora JMS, Portich JP, Paz AA, Silla L, Balsan AM, Schirmer FD, Franz JPM, da-Silveira LM, Breunig RC, Petersen V, Sosnoski M, Mesquita NF, Volpato FCZ, Sganzerla D, Falavigna M, Rosa RG, and Zavascki AP
- Subjects
- Aged, Humans, Immunization, Passive, Male, Middle Aged, Plasma, SARS-CoV-2, Treatment Outcome, COVID-19 Serotherapy, COVID-19 therapy
- Abstract
Background: The effects of convalescent plasma (CP) therapy in hospitalised patients with coronavirus disease 2019 (COVID-19) remain uncertain. This study investigates the effect of CP on clinical improvement in these patients., Methods: This is an investigator-initiated, randomised, parallel arm, open-label, superiority clinical trial. Patients were randomly (1:1) assigned to two infusions of CP plus standard of care (SOC) or SOC alone. The primary outcome was the proportion of patients with clinical improvement 28 days after enrolment., Results: A total of 160 (80 in each arm) patients (66.3% critically ill, 33.7% severely ill) completed the trial. The median (interquartile range (IQR)) age was 60.5 (48-68) years; 58.1% were male and the median (IQR) time from symptom onset to randomisation was 10 (8-12) days. Neutralising antibody titres >1:80 were present in 133 (83.1%) patients at baseline. The proportion of patients with clinical improvement on day 28 was 61.3% in the CP+SOC group and 65.0% in the SOC group (difference -3.7%, 95% CI -18.8-11.3%). The results were similar in the severe and critically ill subgroups. There was no significant difference between CP+SOC and SOC groups in pre-specified secondary outcomes, including 28-day mortality, days alive and free of respiratory support and duration of invasive ventilatory support. Inflammatory and other laboratory marker values on days 3, 7 and 14 were similar between groups., Conclusions: CP+SOC did not result in a higher proportion of clinical improvement on day 28 in hospitalised patients with COVID-19 compared to SOC alone., Competing Interests: Conflict of interest: L. Sekine has nothing to disclose. Conflict of interest: B. Arns has nothing to disclose. Conflict of interest: B.R. Fabro has nothing to disclose. Conflict of interest: M.M. Cipolatt has nothing to disclose. Conflict of interest: R.R.G. Machado received support from “Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)” (2017/24769-2). Conflict of interest: E.L. Durigon has nothing to disclose. Conflict of interest: E. Parolo has nothing to disclose. Conflict of interest: J.A.S. Pellegrini has nothing to disclose. Conflict of interest: M.V. Viana has nothing to disclose. Conflict of interest: P. Schwarz has nothing to disclose. Conflict of interest: T.C. Lisboa has nothing to disclose. Conflict of interest: J.M.S. Dora has nothing to disclose. Conflict of interest: J.P. Portich has nothing to disclose. A.A. Paz has nothing to disclose. L. Silla has nothing to disclose. A.M. Balsan has nothing to disclose. Conflict of interest: F.d-S. Schirmer has nothing to disclose. Conflict of interest: J.P.M. Franz has nothing to disclose. Conflict of interest: L.M. da-Silveira has nothing to disclose. Conflict of interest: R.C. Breunig has nothing to disclose. Conflict of interest: V. Petersen has nothing to disclose. Conflict of interest: M. Sosnoski has nothing to disclose. Conflict of interest: N.F. Mesquita has nothing to disclose. Conflict of interest: F.C.Z. Volpato has nothing to disclose. Conflict of interest: D. Sganzerla has nothing to disclose. Conflict of interest: M. Falavigna has nothing to disclose. Conflict of interest: R.G. Rosa received research grants from Brazilian Ministry of Health. Conflict of interest: A.P. Zavascki is a research fellow of the National Council for Scientific and Technological Development (CNPq), Ministry of Science and Technology, Brazil (304226/2018-1), and receives a research grant not related to this work from Pfizer (WI242215 2018)., (Copyright ©The authors 2022.)
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- 2022
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42. Rationale and Design of the COVID-19 Outpatient Prevention Evaluation (COPE - Coalition V) Randomized Clinical Trial: Hydroxychloroquine vs. Placebo in Non-Hospitalized Patients.
- Author
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Oliveira Junior HA, Ferri CP, Boszczowski I, Oliveira GBF, Cavalcanti AB, Rosa RG, Lopes RD, Azevedo LCP, Veiga VC, Berwanger O, and Avezum Á
- Subjects
- Adult, Humans, Outpatients, SARS-CoV-2, Treatment Outcome, Hydroxychloroquine adverse effects, Hydroxychloroquine therapeutic use, COVID-19 Drug Treatment
- Abstract
Background: Despite the need for targeting specific therapeutic options for coronavirus disease 2019 (COVID-19), there has been no evidence of effectiveness of any specific treatment for the outpatient clinical setting. There are few randomized studies evaluating hydroxychloroquine (HCQ) in non-hospitalized patients. These studies indicate no benefit from the use of HCQ, but they assessed different primary outcomes and presented important biases for outcome evaluation., Objective: To evaluate if HCQ may prevent hospitalization due to COVID-19 compared to a matching placebo., Methods: The COVID-19 Outpatient Prevention Evaluation (COPE) study is a pragmatic, randomized, double-blind, placebo-controlled clinical trial evaluating the use of HCQ (800 mg on day 1 and 400 mg from day 2 to day 7) or matching placebo for the prevention of hospitalization due to COVID-19 in early non-hospitalized confirmed or suspected cases. Inclusion criteria are adults (≥ 18 years) seeking medical care with mild symptoms of COVID-19, with randomization ≤ 7 days after symptom onset, without indication of hospitalization at study screening, and with at least one risk factor for complication (> 65 years; hypertension; diabetes mellitus; asthma; chronic obstructive pulmonary disease or other chronic lung diseases; smoking; immunosuppression; or obesity). All hypothesis tests will be two-sided. A p-value < 0.05 will be considered statistically significant in all analyses. Clinicaltrials.gov: NCT04466540., Results: Clinical outcomes will be centrally adjudicated by an independent clinical event committee blinded to the assigned treatment groups. The primary efficacy endpoint will be assessed following the intention-to-treat principle., Conclusion: This study has the potential to reliably answer the scientific question of HCQ use in outpatients with COVID-19. To our knowledge, this is the largest trial evaluating HCQ in non-hospitalized individuals with COVID-19.
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- 2022
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43. Risk factors for multidrug-resistant bacteremia in hospitalized cancer patients with febrile neutropenia: a cohort study.
- Author
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Rosa RG, Goldani LZ, and dos Santos RP
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- Adolescent, Adult, Aged, Aged, 80 and over, Cohort Studies, Female, Hospitalization, Humans, Male, Middle Aged, Neoplasms therapy, Prospective Studies, Risk Factors, Tertiary Care Centers, Young Adult, Bacteremia epidemiology, Bacteria drug effects, Bacteria isolation & purification, Drug Resistance, Multiple, Bacterial, Febrile Neutropenia complications, Febrile Neutropenia epidemiology, Neoplasms complications
- Abstract
We conducted a prospective cohort study in a single tertiary hospital with the aim of assessing predictors of multidrug-resistant bacteremia in 307 cases of febrile neutropenia in adult patients with cancer. On multivariate analysis using stepwise logistic regression, age (P = .009), duration of neutropenia (P = .022), and presence of an indwelling central venous catheter (P = .022) were associated with bloodstream infection by multidrug-resistant bacteria., (Copyright © 2014 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Mosby, Inc. All rights reserved.)
- Published
- 2014
- Full Text
- View/download PDF
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