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TOPIC: Chest Infections TYPE: Original Investigations PURPOSE: Post-COVID syndrome is defined as signs and symptoms that develop during or after COVID-19, continue for more than 12 weeks, not explained by other diagnosis. Symptoms are variable and involve any organ system1. The syndrome and risk factors are still under investigation. This study aimed to describe symptoms present at 2 and 6-month follow-up of patients with COVID-19 discharged from a tertiary hospital in Brazil and investigate association of post-COVID syndrome with severity of acute illness. METHODS: This is an observational study. Demographic characteristics and data from hospital admission were obtained through review of medical records. Patients that were admitted to Clementino Fraga Filho University Hospital with laboratory confirmed COVID-19 from March to December, 2020 were eligible to follow-up at the Post-COVID outpatient clinic. Appointments were scheduled 2 and 6 months after discharge. Symptoms and limitations were obtained. Patients were stratified into groups based on severity of acute phase: mild, moderate, severe pneumonia and critical disease2. RESULTS: 90 patients were included in the 2-month and 67 in the 6-month assessment. Average age was 60y and 52,2% were female. 24 patients had pneumonia, 52 severe pneumonia and 14 critical disease. There were no differences between groups regarding sex, age or comorbidities. At admission, patients with severe and critical disease had higher prevalence of cough (p=0.001) and dyspnea (p

Background Methods for assessing the level of understanding of trial-related information during the informed consent (IC) process in developing countries are lacking. Purpose To assess the understanding and retention of trial-related information presented in the IC process by administering an informed consent assessment instrument (ICAI) to participants in a clinical trial for a new tuberculosis (TB) regimen being conducted in Rio de Janeiro (Brazil). Methods The format of the ICAI was based on the language and structure of the United States National Cancer Institute’s IC comprehension checklist. The ICAI was designed to assess points of the RioMAR study IC process that addressed the principles of research ethics requested by Brazilian Regulatory Authority: autonomy, beneficence, non-maleficence, and justice. Briefly, (1) Is the respondent participating in a clinical trial? (2) Are two different treatments being evaluated? (3) Is the treatment arm chosen by chance? (4) Is an HIV test required? (5) Are liver function tests required? (6) Can participants leave the study at any time? (7) Are the risks and benefits of taking part in the study clear? (8) May pregnant women participate in the study? (9) Can one of the study drugs reduce the effectiveness of contraceptives? (10) Are patients paid to participate in the study? The ICAI was applied at two time points: immediately after enrollment in the clinical trial and 2 months later. Results A total of 61 patients who enrolled in the RioMAR study participated in this study. The percentage of correct answers to all questions was 82% at the time of the first ICAI; 31 participants (51%) did not recall that an HIV test was required (question 4) and 43 (70%) did not know that they could leave the study (question 6). Other individual questions were answered correctly by at least 76% of participants. There was no association between incorrect answers and age, gender, monthly family income, neighborhood, or level of education (p > 0.07). When the responses to the first and the second ICAI questions were compared, 15% or more of participants had conflicting answers to 5 of the 10 questions. Limitations The ICAI uses dichotomous responses, leading to a 50% chance of guessing the correct answers. Two questions were asked only of women. Finally, only 6 of the 10 questions on the current version of the ICAI apply to most trials; others are trial-specific. Conclusions The ICAI may be adapted to an individual trial and may prove to be a useful tool following a consent discussion to identify issues not fully understood by the research participants, thus prompting study staff to re-explain topics, possibly in a more elementary manner.

OBJETIVO: Estimar a prevalência de resistência primária aos medicamentos do esquema básico de tratamento antituberculose em pacientes com tuberculose pulmonar virgens de tratamento sem fatores de risco conhecidos para resistência primária, e identificar os possíveis fatores associados à resistência medicamentosa. MÉTODOS: Estudo transversal exploratório com a análise de prontuários de pacientes que participaram de dois ensaios clínicos de tuberculose sensível entre 1&º de novembro de 2004 e 31 de março de 2011 no Ambulatório Prof. Newton Bethlem do Instituto de Doenças do Tórax da Universidade Federal do Rio de Janeiro, Rio de Janeiro (RJ). Os critérios de inclusão foram ter idade > 18 anos, ter pesquisa direta de BAAR positiva na primeira amostra de escarro, ter cultura positiva para Mycobacterium tuberculosis, ter realizado testes de sensibilidade aos fármacos, ser virgem de tratamento para tuberculose e não ter história de prisão, hospitalização ou contato com caso de tuberculose resistente. RESULTADOS: Foram incluídos 209 pacientes. A prevalência de resistência primária geral foi de 16,3%. A prevalência geral de resistência à isoniazida e à estreptomicina foi, respectivamente, 9,6% e 9,1%, enquanto a prevalência de monorresistência à isoniazida e à estreptomicina foi de, respectivamente, 5,8% e 6,8%. A prevalência de resistência a dois ou mais fármacos foi de 3,8%, e a prevalência de tuberculose multirresistente foi de 0,5%. Não foram observadas associações estatisticamente significativas entre as variáveis estudadas e resultados do teste de sensibilidade aos fármacos. CONCLUSÕES: Na amostra estudada, a prevalência de resistência primária foi elevada apesar da ausência de fatores de risco conhecidos.

To estimate the prevalence of primary resistance to the drugs in the basic treatment regimen for tuberculosis in treatment-naïve patients with pulmonary tuberculosis and no known risk factors for such resistance, as well as to identify factors potentially associated with drug resistance.This was an exploratory cross-sectional study. We analyzed the medical records of the subjects enrolled in two clinical trials of treatments for drug-susceptible tuberculosis between November 1, 2004 and March 31, 2011 at the Prof. Newton Bethlem Outpatient Clinic of the Federal University of Rio de Janeiro Thoracic Diseases Institute, located in the city of Rio de Janeiro, Brazil. The inclusion criteria were being18 years of age, testing positive for AFB in the first sputum sample, having a positive culture for Mycobacterium tuberculosis, having undergone drug susceptibility testing, and being treatment-naïve. Patients with a history of imprisonment or hospitalization were excluded, as were those who had been in contact with drug-resistant tuberculosis patients.We included 209 patients. The overall prevalence of primary drug resistance was 16.3%. The overall prevalence of resistance to isoniazid and streptomycin was, respectively, 9.6% and 9.1%, compared with 5.8% and 6.8% for single-drug resistance to isoniazid and streptomycin, respectively. The prevalence of resistance to two or more drugs was 3.8%, and the prevalence of multidrug resistance was 0.5%. No statistically significant associations were found between the variables studied and drug susceptibility testing results.In this sample, the prevalence of primary drug resistance was high despite the absence of known risk factors.

OBJECTIVE: To estimate the time elapsed between the onset of symptoms and the initiation of treatment of pulmonary tuberculosis among treatment-naive patients with positive results in sputum smear microscopy, and to evaluate the variables associated with delays in diagnosis and in treatment initiation. METHODS: This was a descriptive exploratory study involving 199 treatment-naive tuberculosis patients > 12 years of age with AFB-positive sputum smear microscopy results between 2006 and 2008. At their first (treatment initiation) visit to a primary health care clinic in the city of Nova Iguacu, Brazil, the patients were interviewed and their ancillary test results were reviewed. RESULTS: The medians (and respective interquartile ranges) of the time from symptom onset to the initiation of treatment of pulmonary tuberculosis, from symptom onset to seeking medical attention, from entry into care to diagnosis, and from entry into care to treatment initiation, in weeks, were 11 (6-24), 8 (4-20), 2 (1-8), and 1 (1-1), respectively. The variables gender, age, level of education, previous use of antibiotics, HIV status, site of first medical visit, and radiological extent of tuberculosis showed no associations with the time from entry into care to diagnosis and to treatment initiation. The main reason for the delay in seeking medical attention reported by the patients was their inability to recognize their symptoms as indicators of a disease. CONCLUSIONS: Among the patients studied, there was an unacceptably long delay between the onset of symptoms and the initiation of tuberculosis treatment.

To estimate the time elapsed between the onset of symptoms and the initiation of treatment of pulmonary tuberculosis among treatment-naïve patients with positive results in sputum smear microscopy, and to evaluate the variables associated with delays in diagnosis and in treatment initiation.This was a descriptive exploratory study involving 199 treatment-naïve tuberculosis patients12 years of age with AFB-positive sputum smear microscopy results between 2006 and 2008. At their first (treatment initiation) visit to a primary health care clinic in the city of Nova Iguaçu, Brazil, the patients were interviewed and their ancillary test results were reviewed.The medians (and respective interquartile ranges) of the time from symptom onset to the initiation of treatment of pulmonary tuberculosis, from symptom onset to seeking medical attention, from entry into care to diagnosis, and from entry into care to treatment initiation, in weeks, were 11 (6-24), 8 (4-20), 2 (1-8), and 1 (1-1), respectively. The variables gender, age, level of education, previous use of antibiotics, HIV status, site of first medical visit, and radiological extent of tuberculosis showed no associations with the time from entry into care to diagnosis and to treatment initiation. The main reason for the delay in seeking medical attention reported by the patients was their inability to recognize their symptoms as indicators of a disease.Among the patients studied, there was an unacceptably long delay between the onset of symptoms and the initiation of tuberculosis treatment.

Summary Background New treatments are needed to shorten the time required to cure tuberculosis and to treat drug-resistant strains. The fluoroquinolone moxifloxacin is a promising new agent that might have additive activity to existing antituberculosis agents. We assessed the activity and safety of moxifloxacin in the initial stage of tuberculosis treatment. Methods We undertook a phase II, double-blind, randomised controlled trial of a regimen that included moxifloxacin in adults with sputum smear-positive tuberculosis at one hospital in Rio de Janeiro, Brazil. 170 participants received isoniazid, rifampicin, and pyrazinamide at standard doses and were assigned by permuted block randomisation to receive either moxifloxacin (400 mg) with an ethambutol placebo (n=85) or ethambutol (15–20 mg/kg) plus moxifloxacin placebo (n=85) 5 days per week for 8 weeks. The primary endpoint was the proportion of patients whose sputum culture had converted to negative by week 8. Analysis was by modified intention to treat (ITT); patients whose baseline cultures were negative, contaminated, or contained drug-resistant Mycobacterium tuberculosis were excluded from the analysis. Additionally, all missing 8-week results were deemed treatment failures. This study is registered with ClinicalTrials.gov, number NCT00082173. Findings 74 patients assigned to the moxifloxacin group and 72 in the ethambutol group were included in the modified ITT population. 125 patients had 8-week data (moxifloxacin n=64, ethambutol n=61); the main reason for absence of data was culture contamination. At 8 weeks, culture conversion to negative had occurred in 59 (80%) of 74 patients in the moxifloxacin group compared with 45 (63%) of 72 in the ethambutol group (difference 17·2%, 95% CI 2·8–31·7; p=0·03). There were 16 adverse events (eight in each group) in 12 patients. Only one event was judged related to study drug (grade 3 cutaneous reaction in the ethambutol group). Interpretation Moxifloxacin improved culture conversion in the initial phase of tuberculosis treatment. Trials to assess whether moxifloxacin can be used to shorten the duration of tuberculosis treatment are justified. Funding US Food and Drug Administration Office of Orphan Product Development, with additional support from the US National Institutes of Health.

Background Being a contact of a pulmonary tuberculosis (TB) case is a risk factor for active and latent TB. The objective of this study is to determine the contact tracing yield using two different programmatic definitions of close contact in the city of Rio de Janeiro, Brazil. Methods This is a retrospective quasi-experimental study. Data were obtained by reviewing the medical records from TB index cases and their close contacts admitted to the Outpatient TB Clinic of the Institute of Thoracic Diseases, University of Rio de Janeiro. From January 2001 to December 2004, a close contact was defined as an individual who shared an enclosed space with a TB index case for a total period of ≥ 100 hours, whereas from January 2005 to December 2008 the definition of close contact was changed to an individual who shared an enclosed space with a TB index case ≥ 4 hours a week. The primary outcome of this study was newly diagnosed pulmonary TB cases and the secondary outcome was the prevalence of latent TB infection (LTBI) among close contacts during both periods. Results From 2001–2004, 810 close contacts from 257 index cases were evaluated and the prevalence of active TB and LTBI were 2% (16/810) and 62% (496/794), respectively. From 2005–2008, 1,310 close contacts from 369 index cases were identified and the prevalence of active TB and LTBI were 2.7% (35/1,310) and 69% (877/1,275), respectively. There was not a statically significant difference in the detection of active TB (p = 0.3) between the 2 time periods, but the detection of LTBI was significant higher (p = 0.003). The number needed to screen (contacts/new cases) decreased from 50 to 37 and the number need to contact trace (index cases/new cases) decreased from 16 to 10 from 2001–2004 to 2005–2008. Conclusion In conclusion, the findings of this study suggest that the less conservative definition of TB close contacts (sharing space ≥ 4 h/week) can be a helpful tool for increasing the rate of diagnosis for newly active pulmonary TB cases and for the detection of LTBI among contacts of active pulmonary TB cases.