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546 results on '"Merlo, Christian A."'

2. Transfusing convalescent plasma as post-exposure prophylaxis against SARS-CoV-2 infection: a double-blinded, phase 2 randomized, controlled trial

Author

Shoham, Shmuel, Bloch, Evan M, Casadevall, Arturo, Hanley, Daniel, Lau, Bryan, Gebo, Kelly, Cachay, Edward, Kassaye, Seble G, Paxton, James H, Gerber, Jonathan, Levine, Adam C, Naeim, Arash, Currier, Judith, Patel, Bela, Allen, Elizabeth S, Anjan, Shweta, Appel, Lawrence, Baksh, Sheriza, Blair, Paul W, Bowen, Anthony, Broderick, Patrick, Caputo, Christopher A, Cluzet, Valerie, Cordisco, Marie Elena, Cruser, Daniel, Ehrhardt, Stephan, Forthal, Donald, Fukuta, Yuriko, Gawad, Amy L, Gniadek, Thomas, Hammel, Jean, Huaman, Moises A, Jabs, Douglas A, Jedlicka, Anne, Karlen, Nicky, Klein, Sabra, Laeyendecker, Oliver, Lane, Karen, McBee, Nichol, Meisenberg, Barry, Merlo, Christian, Mosnaim, Giselle, Park, Han-Sol, Pekosz, Andrew, Petrini, Joann, Rausch, William, Shade, David M, Shapiro, Janna R, Singleton, J Robinson, Sutcliffe, Catherine, Thomas, David L, Yarava, Anusha, Zand, Martin, Zenilman, Jonathan M, Tobian, Aaron AR, and Sullivan, David J

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Biodefense, Lung, Pneumonia, Clinical Trials and Supportive Activities, Vaccine Related, Prevention, Infectious Diseases, Emerging Infectious Diseases, Clinical Research, Infection, Good Health and Well Being, Humans, Adolescent, Adult, SARS-CoV-2, COVID-19, Post-Exposure Prophylaxis, COVID-19 Serotherapy, Double-Blind Method, Immunization, Passive, post-exposure-prophylaxis, convalescent plasma, transfusion, Biological Sciences, Medical and Health Sciences, Microbiology, Clinical sciences
Abstract

BackgroundThe efficacy of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) convalescent plasma (CCP) for preventing infection in exposed, uninfected individuals is unknown. CCP might prevent infection when administered before symptoms or laboratory evidence of infection.MethodsThis double-blinded, phase 2 randomized, controlled trial (RCT) compared the efficacy and safety of prophylactic high titer (≥1:320 by Euroimmun ELISA) CCP with standard plasma. Asymptomatic participants aged ≥18 years with close contact exposure to a person with confirmed coronavirus disease 2019 (COVID-19) in the previous 120 hours and negative SARS-CoV-2 test within 24 hours before transfusion were eligible. The primary outcome was new SARS-CoV-2 infection.ResultsIn total, 180 participants were enrolled; 87 were assigned to CCP and 93 to control plasma, and 170 transfused at 19 sites across the United States from June 2020 to March 2021. Two were excluded for screening SARS-CoV-2 reverse transcription polymerase chain reaction (RT-PCR) positivity. Of the remaining 168 participants, 12/81 (14.8%) CCP and 13/87 (14.9%) control recipients developed SARS-CoV-2 infection; 6 (7.4%) CCP and 7 (8%) control recipients developed COVID-19 (infection with symptoms). There were no COVID-19-related hospitalizations in CCP and 2 in control recipients. Efficacy by restricted mean infection free time (RMIFT) by 28 days for all SARS-CoV-2 infections (25.3 vs 25.2 days; P = .49) and COVID-19 (26.3 vs 25.9 days; P = .35) was similar for both groups.ConclusionsAdministration of high-titer CCP as post-exposure prophylaxis, although appearing safe, did not prevent SARS-CoV-2 infection.Clinical trials registrationNCT04323800.

Published
2023

3. Contemporary trends in PGD incidence, outcomes, and therapies

Author

Cantu, Edward, Diamond, Joshua M, Cevasco, Marisa, Suzuki, Yoshi, Crespo, Maria, Clausen, Emily, Dallara, Laura, Ramon, Christian V, Harmon, Michael T, Bermudez, Christian, Benvenuto, Luke, Anderson, Michaela, Wille, Keith M, Weinacker, Ann, Dhillon, Gundeep S, Orens, Jonathan, Shah, Pali, Merlo, Christian, Lama, Vibha, McDyer, John, Snyder, Laurie, Palmer, Scott, Hartwig, Matt, Hage, Chadi A, Singer, Jonathan, Calfee, Carolyn, Kukreja, Jasleen, Greenland, John R, Ware, Lorraine B, Localio, Russel, Hsu, Jesse, Gallop, Robert, and Christie, Jason D

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Organ Transplantation, Lung, Transplantation, Clinical Research, Good Health and Well Being, Female, Pregnancy, Humans, Primary Graft Dysfunction, Incidence, Preimplantation Diagnosis, Prospective Studies, Retrospective Studies, Lung Transplantation, primary graft dysfunction, lung transplantation, ECMO, bridge to transplant, outcomes and lung allocation score, Cardiorespiratory Medicine and Haematology, Surgery, Cardiovascular medicine and haematology, Clinical sciences
Abstract

BackgroundWe sought to describe trends in extracorporeal membrane oxygenation (ECMO) use, and define the impact on PGD incidence and early mortality in lung transplantation.MethodsPatients were enrolled from August 2011 to June 2018 at 10 transplant centers in the multi-center Lung Transplant Outcomes Group prospective cohort study. PGD was defined as Grade 3 at 48 or 72 hours, based on the 2016 PGD ISHLT guidelines. Logistic regression and survival models were used to contrast between group effects for event (i.e., PGD and Death) and time-to-event (i.e., death, extubation, discharge) outcomes respectively. Both modeling frameworks accommodate the inclusion of potential confounders.ResultsA total of 1,528 subjects were enrolled with a 25.7% incidence of PGD. Annual PGD incidence (14.3%-38.2%, p = .0002), median LAS (38.0-47.7 p = .009) and the use of ECMO salvage for PGD (5.7%-20.9%, p = .007) increased over the course of the study. PGD was associated with increased 1 year mortality (OR 1.7 [95% C.I. 1.2, 2.3], p = .0001). Bridging strategies were not associated with increased mortality compared to non-bridged patients (p = .66); however, salvage ECMO for PGD was significantly associated with increased mortality (OR 1.9 [1.3, 2.7], p = .0007). Restricted mean survival time comparison at 1-year demonstrated 84.1 days lost in venoarterial salvaged recipients with PGD when compared to those without PGD (ratio 1.3 [1.1, 1.5]) and 27.2 days for venovenous with PGD (ratio 1.1 [1.0, 1.4]).ConclusionsPGD incidence continues to rise in modern transplant practice paralleled by significant increases in recipient severity of illness. Bridging strategies have increased but did not affect PGD incidence or mortality. PGD remains highly associated with mortality and is increasingly treated with salvage ECMO.

Published
2022

6. Personalized cardiovascular risk assessment in Rheumatoid Arthritis patients using circulating molecular profiles and their modulation by TNFi, IL6Ri, and JAKinibs

Author

Muñoz-Barrera, Laura, Perez-Sanchez, Carlos, Ortega-Castro, Rafaela, Corrales, Sagrario, Luque-Tevar, Maria, Cerdó, Tomás, Sanchez-Pareja, Ismael, Font, Pilar, Lopez-Mejías, Raquel, Calvo, Jerusalem, Abalos-Aguilera, M.Carmen, Ruiz-Vilchez, Desiree, Segui, Pedro, Merlo, Christian, Perez-Venegas, José, Ruiz Montesino, Ma Dolores, Rodriguez- Escalera, Carlos, Barco, Carmen Romero, Fernandez-Nebro, Antonio, Vazque, Natalia Mena, Marenco, Jose Luis, Montañes, Julia Uceda, Godoy-Navarrete, Javier, Cabezas-Lucena, Alba Ma, Estevez, Eduardo Collantes, Aguirre, Ma Angeles, González-Gay, Miguel A., Barbarroja, Nuria, Escudero-Contreras, Alejandro, and Lopez-Pedrera, Chary

Published
2024
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8. Development and validation of primary graft dysfunction predictive algorithm for lung transplant candidates

Author

Diamond, Joshua M., Anderson, Michaela R., Cantu, Edward, Clausen, Emily S., Shashaty, Michael G.S., Kalman, Laurel, Oyster, Michelle, Crespo, Maria M., Bermudez, Christian A., Benvenuto, Luke, Palmer, Scott M., Snyder, Laurie D., Hartwig, Matthew G., Wille, Keith, Hage, Chadi, McDyer, John F., Merlo, Christian A., Shah, Pali D., Orens, Jonathan B., Dhillon, Ghundeep S., Lama, Vibha N., Patel, Mrunal G., Singer, Jonathan P., Hachem, Ramsey R., Michelson, Andrew P., Hsu, Jesse, Russell Localio, A., and Christie, Jason D.

Published
2024
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11. Outcomes of SOT Recipients With COVID-19 in Different Eras of COVID-19 Therapeutics.

Author

Sait, Afrah, Chiang, Teresa, Marr, Kieren, Massie, Allan, Cochran, Willa, Shah, Pali, Brennan, Daniel, Thomas, Alvin, Mehta Steinke, Seema, Permpalung, Nitipong, Shoham, Shmuel, Merlo, Christian, Jain, Tania, Boyarsky, Brian, Charnaya, Olga, Gurakar, Ahmet, Sharma, Kavita, Durand, Christine, Werbel, William, Ostrander, Darin, Desai, Niraj, Kim, Min, Alasfar, Sami, Bloch, Evan, Tobian, Aaron, Garonzik-Wang, Jacqueline, Segev, Dorry, Avery, Robin, and Huang, Chiung-yu

Abstract

BACKGROUND: Few reports have focused on newer coronavirus disease 2019 (COVID-19) therapies (remdesivir, dexamethasone, and convalescent plasma) in solid organ transplant recipients; concerns had been raised regarding possible adverse impact on allograft function or secondary infections. METHODS: We studied 77 solid organ transplant inpatients with COVID-19 during 2 therapeutic eras (Era 1: March-May 2020, 21 patients; and Era 2: June-November 2020, 56 patients) and 52 solid organ transplant outpatients. RESULTS: In Era 1, no patients received remdesivir or dexamethasone, and 4 of 21 (19.4%) received convalescent plasma, whereas in Era 2, remdesivir (24/56, 42.9%), dexamethasone (24/56, 42.9%), and convalescent plasma (40/56, 71.4%) were commonly used. Mortality was low across both eras, 4 of 77 (5.6%), and rejection occurred in only 2 of 77 (2.8%) inpatients; infections were similar in hypoxemic patients with or without dexamethasone. Preexisting graft dysfunction was associated with greater need for hospitalization, higher severity score, and lower survival. Acute kidney injury was present in 37.3% of inpatients; renal function improved more rapidly in patients who received remdesivir and convalescent plasma. Post-COVID-19 renal and liver function were comparable between eras, out to 90 d. CONCLUSIONS: Newer COVID-19 therapies did not appear to have a deleterious effect on allograft function, and infectious complications were comparable.

Published
2022

21. Safety and efficacy of vanzacaftor–tezacaftor–deutivacaftor in adults with cystic fibrosis: randomised, double-blind, controlled, phase 2 trials

Author

Horsley, Alexander, Nash, Edward F., Bakker, Marleen, van der Meer, Renske, Merkus, Petrus, Majoor, Christof, McCoy, Karen, Billings, Joanne, Pancham, Krishna, Tolle, James, Quick, Bryon, Uluer, Ahmet, DiMango, Emily, Rao, Adupa, Reyes, Santiago, Klingsberg, Ross, Barreto, Celeste, Ortega, Victor, Willey-Courand, Donna, Schwarz, Carsten, Sutharsan, Sivagurunathan, Fischer, Rainald, Davies, Jane, Duckers, Jamie, Doe, Simon, Heijerman, Harry, Solomon, George M., Merlo, Christian, Griffonnet, Jennifer, Pilewski, Joseph, Dunitz, Jordan, Sheikh, Saba, Rubenstein, Ronald C., Rosenbluth, Daniel B., Liou, Theodore, Indihar, Maria, Yonker, Lael, Nasr, Samya, Brown, Cynthia D., Sawicki, Gregory S., Ruddy, Jennifer, Garcia, Bryan, Braun, Andrew, Gifford, Alex H., Mehdi, Nighat, Tupayachi Ortiz, Maria, Jain, Raksha, Calimano, Francisco J., Johannes, Jimmy, Daines, Cori L., Fullmer, Jason, Mermis, Joel, Barrios, Christopher, Ly, Ngoc, Casserly, Brian P., Eisenmann, Stephan, Hebestreit, Helge, Kiefer, Alexander, MacGregor, Gordon, Peckham, Daniel, Ledson, Martin, Van Braeckel, Eva, McElvaney, Noel Gerard, McKone, Edward, Plant, Barry, Burr, Lucy, Smith, Daniel J., Middleton, Peter, Wilson, John, Uluer, Ahmet Z, Azevedo, Pilar, Indihar, Veronica, Keating, Claire, Mall, Marcus A, McKone, Edward F, Ramsey, Bonnie W, Rowe, Steven M, Rubenstein, Ronald C, Taylor-Cousar, Jennifer L, Tullis, Elizabeth, Yonker, Lael M, Chu, Chenghao, Lam, Anna P, Nair, Nitin, Sosnay, Patrick R, Tian, Simon, Van Goor, Fredrick, Viswanathan, Lakshmi, Waltz, David, Wang, Linda T, and Xi, Yingmei

Published
2023
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27. Investigation of CFTR Function in Human Nasal Epithelial Cells Informs Personalized Medicine.

Author

Pion, Audrey, Kavanagh, Erin, Joynt, Anya T., Raraigh, Karen S., Vanscoy, Lori, Langfelder-Schwind, Elinor, McNamara, John, Moore, Brooke, Patel, Shivani, Merlo, Kate, Temme, Renee, Capurro, Valeria, Pesce, Emanuela, Merlo, Christian, Pedemonte, Nicoletta, Cutting, Garry R., and Sharma, Neeraj

Subjects
LUNGS, CYSTIC fibrosis transmembrane conductance regulator, NASAL mucosa, INDIVIDUALIZED medicine, EPITHELIAL cells
Abstract

We broaden the clinical versatility of human nasal epithelial (HNE) cells. HNEs were isolated from 10 participants harboring cystic fibrosis transmembrane conductance regulator (CFTR) variants: 9 with rare variants (Q359R [n = 2], G480S, R334W [n = 5], and R560T) and 1 harboring R117H;7T;TG10/5T;TG12. Cultures were differentiated at the air–liquid interface. CFTR function was measured in Ussing chambers at three conditions: baseline, ivacaftor, and elexacaftor + tezacaftor + ivacaftor (ETI). Four participants initiated modulators. Q359R HNEs had 5.4% (% wild-type) baseline CFTR function and 25.5% with ivacaftor. With therapy, sweat [Cl−] decreased and symptoms resolved. G480S HNEs had 4.1% baseline and 32.1% CFTR function with ETI. Clinically, forced expiratory volume in 1 second increased and sweat [Cl−] decreased (119 to 46 mmol/L) with ETI. In vitro cultures derived from 5 participants harboring R334W showed a moderate increase in CFTR function with exposure to modulators. For one of these participants, ETI was begun in vivo; symptoms and forced expiratory volume in 1 second improved. The c.1679G>C (R560T) HNEs had less than 4% baseline CFTR function and no modulator response. RNA analysis confirmed that c.1679G>C completely missplices. A symptomatic patient harboring R117H;7T;TG10/5T;TG12 exhibited reduced CFTR function (17.5%) in HNEs, facilitating a diagnosis of mild CF. HNEs responded to modulators (ivacaftor: 32.8%, ETI: 55.5%), and, since beginning therapy, lung function improved. We reaffirm HNE use for guiding therapeutic approaches, inform predictions on modulator response (e.g., R334W), and closely assess variants that affect splicing (e.g., c.1679G>C). Notably, functional studies in HNEs harboring R117H;7T;TG10/5T;TG12 facilitated a diagnosis of mild CF, suggesting the use for HNE functional studies as a clinical diagnostic test. [ABSTRACT FROM AUTHOR]

Published
2024
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34. Development and validation of primary graft dysfunction predictive algorithm for lung transplant candidates

Author

Diamond, Joshua M., primary, Anderson, Michaela R., additional, Cantu, Edward, additional, Clausen, Emily S., additional, Shashaty, Michael G.S., additional, Kalman, Laurel, additional, Oyster, Michelle, additional, Crespo, Maria M., additional, Bermudez, Christian A., additional, Benvenuto, Luke, additional, Palmer, Scott M., additional, Snyder, Laurie D., additional, Hartwig, Matthew G., additional, Wille, Keith, additional, Hage, Chadi, additional, McDyer, John F., additional, Merlo, Christian A., additional, Shah, Pali D., additional, Orens, Jonathan B., additional, Dhillon, Ghundeep S., additional, Lama, Vibha N., additional, Patel, Mrunal G., additional, Singer, Jonathan P., additional, Hachem, Ramsey R., additional, Michelson, Andrew P., additional, Hsu, Jesse, additional, Russell Localio, A., additional, and Christie, Jason D., additional

Published
2023
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44. Use of adenine base editing and homology-independent targeted integration strategies to correct the cystic fibrosis causing variant, W1282X

Author

Mention, Karen, primary, Cavusoglu-Doran, Kader, additional, Joynt, Anya T, additional, Santos, Lúcia, additional, Sanz, David, additional, Eastman, Alice C, additional, Merlo, Christian, additional, Langfelder-Schwind, Elinor, additional, Scallan, Martina F, additional, Farinha, Carlos M, additional, Cutting, Garry R, additional, Sharma, Neeraj, additional, and Harrison, Patrick T, additional

Published
2023
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49. Health-Related Quality of Life Outcome Measures in Individuals With Hereditary Hemorrhagic Telangiectasia: A Scoping Review.

Author

Gong, Anna J., Garg, Tushar, Khalil, Adham, Gowda, Prateek C., Mathai, Stephen C., Rowan, Nicholas R., Merlo, Christian A., and Weiss, Clifford R.

Subjects
HEREDITARY hemorrhagic telangiectasia, QUALITY of life, GASTROINTESTINAL hemorrhage, BIBLIOGRAPHIC databases, RANDOMIZED controlled trials, ARTERIOVENOUS malformation
Abstract

Background: Studies evaluating health-related quality of life (HRQOL) in patients with hereditary hemorrhagic telangiectasia (HHT) have expanded rapidly in the past decade. These studies have evaluated QOL aspects ranging from the general QOL for patients living with HHT to intervention-specific outcomes. However, few tools have been fully validated across the spectrum of disease manifestations and interventions in HHT. Objective: In this scoping review, we aim to map the literature on HHT-QOL metrics, identify gaps, inform future QOL research, and facilitate future metric development. Methods: We analyzed articles in English that assessed at least 1 measure of general HRQOL, including physical health, mental health, social health, or intervention-specific QOL in patients with HHT. Searches across 2 bibliographic databases (PubMed and Scopus) yielded 186 articles after duplicates were removed. Sixty-three studies met eligibility criteria: 22 prospective studies (34.9%), 20 retrospective studies (31.7%), 12 cross-sectional studies (17.5%), 6 randomized controlled trials or secondary analyses of a randomized controlled trials (9.5%), 2 qualitative studies (3.2%), and 1 case-control study (1.6%). Two additional studies—1 prospective and 1 cross-sectional study—were identified at the October 2022 14th International HHT Conference and included, making a total of 65 studies. Results: The 65 eligible studies used 30 QOL instruments. Twenty studies characterized baseline HRQOL, and 45 studies evaluated QOL before and after treatment. Of those 45 studies, 37 evaluated HRQOL before and after therapies targeting epistaxis and nasal symptoms, 4 targeted therapies for liver arteriovenous malformations and high-output heart failure, 3 evaluated therapies for both epistaxis and gastrointestinal bleeding, and 1 evaluated treatment targeting gastrointestinal bleeding alone. Conclusions: Comparison of results across studies remains challenging given the heterogeneity in outcomes measures. Further development of HHT-specific patient-reported outcomes instruments that capture the global illness experience of HHT is needed. [ABSTRACT FROM AUTHOR]

Published
2024
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50. The Impact of Donor Smoking on Primary Graft Dysfunction and Mortality after Lung Transplantation.

Author

Diamond, Joshua M., Cantu, Edward, Calfee, Carolyn S., Anderson, Michaela R., Clausen, Emily S., Shashaty, Michael G. S., Courtwright, Andrew M., Kalman, Laurel, Oyster, Michelle, Crespo, Maria M., Bermudez, Christian A., Benvenuto, Luke, Palmer, Scott M., Snyder, Laurie D., Hartwig, Matthew G., Todd, Jamie L., Wille, Keith, Hage, Chadi, McDyer, John F., and Merlo, Christian A.

Subjects
LUNG transplantation, SMOKE, MORTALITY risk factors, SMOKING
Abstract

Rationale: Primary graft dysfunction (PGD) is the leading cause of early morbidity and mortality after lung transplantation. Prior studies implicated proxy-defined donor smoking as a risk factor for PGD and mortality. Objectives: We aimed to more accurately assess the impact of donor smoke exposure on PGD and mortality using quantitative smoke exposure biomarkers. Methods: We performed a multicenter prospective cohort study of lung transplant recipients enrolled in the Lung Transplant Outcomes Group cohort between 2012 and 2018. PGD was defined as grade 3 at 48 or 72 hours after lung reperfusion. Donor smoking was defined using accepted thresholds of urinary biomarkers of nicotine exposure (cotinine) and tobacco-specific nitrosamine (4-[methylnitrosamino]-1-[3-pyridyl]-1-butanol [NNAL]) in addition to clinical history. The donor smoking-PGD association was assessed using logistic regression, and survival analysis was performed using inverse probability of exposure weighting according to smoking category. Measurements and Main Results: Active donor smoking prevalence varied by definition, with 34-43% based on urinary cotinine, 28% by urinary NNAL, and 37% by clinical documentation. The standardized risk of PGD associated with active donor smoking was higher across all definitions, with an absolute risk increase of 11.5% (95% confidence interval [CI], 3.8% to 19.2%) by urinary cotinine, 5.7% (95% CI, 23.4% to 14.9%) by urinary NNAL, and 6.5% (95% CI, 22.8% to 15.8%) defined clinically. Donor smoking was not associated with differential post-lung transplant survival using any definition. Conclusions: Donor smoking associates with a modest increase in PGD risk but not with increased recipient mortality. Use of lungs from smokers is likely safe and may increase lung donor availability. [ABSTRACT FROM AUTHOR]

Published
2024
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