Raphael J Landovitz,Yvett Pinedo,Federico Hinestrosa,Gordon E Crofoot,Cynthia Brinson,Susan Buchbinder,Jean-Michel Molina,Ronnie M Gravett,James B Brock,Moti N Ramgopal,A Lina Rosengren,Igho Ofotokun,Jose Valdez Madruga,Geoffroy Liegeon,Ravindre Panchia,Khuanchai Supparatpinyo,Anchalee Avihingsanon,Catherine Creticos,Shobha Swaminathan,Susanne Doblecki-Lewis,Jorge Rodriguez,Marc Siegel,Shinichi Oka,Thanyawee Puthanakit,Beatriz Grinsztejn,Eduard J Sanders,Javier R Lama,Johannes Lombaard,Nkosiphile Ndlovu,Peggy Hwang,Jiejun Du,Beth Jackson,Brenda Homony,Barbara Evans,Peter Sklar,Michael N Robertson,Rebeca M Plank
BACKGROUNDIslatravir once monthly (qm), a nucleoside reverse transcriptase translocation inhibitor with a long half-life, was evaluated for safety and tolerability in cisgender men and transgender women who have sex with men and are at increased likelihood of HIV-1 exposure.METHODSIMPOWER-24 (NCT04652700) was a double-blind, Phase 3 study. Participants were randomized 2:1 to islatravir 60 mg oral qm or emtricitabine (FTC; 200 mg) coformulated with either tenofovir disoproxil (245 mg) or tenofovir alafenamide (TAF; 25 mg) once daily (qd). After ∼9 months, blinded islatravir was discontinued due to lymphocyte reductions; participants were offered open-label FTC/tenofovir disoproxil or FTC/TAF qd for 20 months.RESULTS494 participants were enrolled (328 islatravir; 166 comparator): 91.5% were cisgender men, 41.7% were White, and median age was 27 years. Mean blinded dosing duration was 4.7 months (islatravir) versus 4.3 months (comparator). 211 participants (64.3%) in the islatravir group and 128 (77.1%) in the comparator group had ≥1 adverse event (AE). Most AEs were mild or moderate, with one AE leading to product discontinuation (islatravir; gastroesophageal reflux). Serious AEs occurred in <2%; none were related to study product. Change in total lymphocytes in the islatravir group at Month 3 was -7.4%; a trend toward recovery was observed after islatravir was stopped. Mean total lymphocytes remained within normal range. No HIV-1 infections occurred in either group during the double-blind phase.CONCLUSIONIslatravir qm was generally well-tolerated; decreases in total lymphocytes were observed with islatravir. Original primary efficacy objectives were not assessed due to early study stoppage.
{"title":"Safety and Tolerability of Oral Islatravir Once Monthly as Pre-Exposure Prophylaxis in Cisgender Men and Transgender Women Who Have an Elevated Likelihood of HIV-1 Exposure: Results From the IMPOWER-24 Randomized Phase 3 Study.","authors":"Raphael J Landovitz,Yvett Pinedo,Federico Hinestrosa,Gordon E Crofoot,Cynthia Brinson,Susan Buchbinder,Jean-Michel Molina,Ronnie M Gravett,James B Brock,Moti N Ramgopal,A Lina Rosengren,Igho Ofotokun,Jose Valdez Madruga,Geoffroy Liegeon,Ravindre Panchia,Khuanchai Supparatpinyo,Anchalee Avihingsanon,Catherine Creticos,Shobha Swaminathan,Susanne Doblecki-Lewis,Jorge Rodriguez,Marc Siegel,Shinichi Oka,Thanyawee Puthanakit,Beatriz Grinsztejn,Eduard J Sanders,Javier R Lama,Johannes Lombaard,Nkosiphile Ndlovu,Peggy Hwang,Jiejun Du,Beth Jackson,Brenda Homony,Barbara Evans,Peter Sklar,Michael N Robertson,Rebeca M Plank","doi":"10.1093/cid/ciag171","DOIUrl":"https://doi.org/10.1093/cid/ciag171","url":null,"abstract":"BACKGROUNDIslatravir once monthly (qm), a nucleoside reverse transcriptase translocation inhibitor with a long half-life, was evaluated for safety and tolerability in cisgender men and transgender women who have sex with men and are at increased likelihood of HIV-1 exposure.METHODSIMPOWER-24 (NCT04652700) was a double-blind, Phase 3 study. Participants were randomized 2:1 to islatravir 60 mg oral qm or emtricitabine (FTC; 200 mg) coformulated with either tenofovir disoproxil (245 mg) or tenofovir alafenamide (TAF; 25 mg) once daily (qd). After ∼9 months, blinded islatravir was discontinued due to lymphocyte reductions; participants were offered open-label FTC/tenofovir disoproxil or FTC/TAF qd for 20 months.RESULTS494 participants were enrolled (328 islatravir; 166 comparator): 91.5% were cisgender men, 41.7% were White, and median age was 27 years. Mean blinded dosing duration was 4.7 months (islatravir) versus 4.3 months (comparator). 211 participants (64.3%) in the islatravir group and 128 (77.1%) in the comparator group had ≥1 adverse event (AE). Most AEs were mild or moderate, with one AE leading to product discontinuation (islatravir; gastroesophageal reflux). Serious AEs occurred in <2%; none were related to study product. Change in total lymphocytes in the islatravir group at Month 3 was -7.4%; a trend toward recovery was observed after islatravir was stopped. Mean total lymphocytes remained within normal range. No HIV-1 infections occurred in either group during the double-blind phase.CONCLUSIONIslatravir qm was generally well-tolerated; decreases in total lymphocytes were observed with islatravir. Original primary efficacy objectives were not assessed due to early study stoppage.","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":"56 1","pages":""},"PeriodicalIF":11.8,"publicationDate":"2026-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147447063","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Lindsay McKenna,Mike Frick,Valentina A Alarcón-Guizado,Geraint Davies,Jennifer J Furin,Lorenzo Guglielmetti,Norbert Heinrich,Marcus Low,Mariama Mahmoud,Vidya Mave,Norbert Ndjeka,Patrick P J Phillips,Samuel Schumacher,Mark Harrington,Carole D Mitnick
Tuberculosis treatment trials have used various comparison strategies. To inform trial design for novel tuberculosis regimens, we applied an existing framework for evaluating when uncontrolled trials might be justified. We conclude that the conditions are not met for tuberculosis treatment and that uncontrolled phase 3 trials should not be performed.
{"title":"When are uncontrolled trials in TB scientifically and ethically justified: Borrowing wisdom from early AIDS clinical trials.","authors":"Lindsay McKenna,Mike Frick,Valentina A Alarcón-Guizado,Geraint Davies,Jennifer J Furin,Lorenzo Guglielmetti,Norbert Heinrich,Marcus Low,Mariama Mahmoud,Vidya Mave,Norbert Ndjeka,Patrick P J Phillips,Samuel Schumacher,Mark Harrington,Carole D Mitnick","doi":"10.1093/cid/ciag175","DOIUrl":"https://doi.org/10.1093/cid/ciag175","url":null,"abstract":"Tuberculosis treatment trials have used various comparison strategies. To inform trial design for novel tuberculosis regimens, we applied an existing framework for evaluating when uncontrolled trials might be justified. We conclude that the conditions are not met for tuberculosis treatment and that uncontrolled phase 3 trials should not be performed.","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":"26 1","pages":""},"PeriodicalIF":11.8,"publicationDate":"2026-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147439296","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Shawn D St Peter, Krow Ampofo, Thomas Brogan, Michael D Cabana, Claudia Espinosa, Todd A Florin, Jeffrey S Gerber, Michelle Gill, Debra L Palazzi, Mark Sawyer, Angela Statile, Derek J Williams, Sheena Patel, Mark I Neuman, Samir S Shah
This paper is part of a larger clinical practice guideline on the diagnosis and management of parapneumonic effusion and empyema in children, developed by the Infectious Diseases Society of America. In this paper, the panel provides recommendations on the appropriate size of thoracostomy tube for drainage. The panel’s recommendations are based upon evidence derived from systematic literature reviews and adhere to a standardized methodology for rating the certainty of evidence and strength of recommendation according to the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) approach.
本文是美国传染病学会（Infectious Diseases Society of America）制定的关于儿童肺旁积液和脓胸的诊断和管理的较大临床实践指南的一部分。在这篇论文中，专家小组就合适的开胸引流管尺寸提出了建议。专家组的建议是基于从系统文献综述中获得的证据，并根据GRADE（建议评估、发展和评估分级）方法坚持对证据的确定性和建议的强度进行评级的标准化方法。
{"title":"2026 Clinical Practice Guideline Update by the Infectious Diseases Society of America and the Pediatric Infectious Diseases Society on The Management of Community-acquired Pneumonia in Infants and Children Older than 3 Months of Age: The Choice of Chest Tube Size","authors":"Shawn D St Peter, Krow Ampofo, Thomas Brogan, Michael D Cabana, Claudia Espinosa, Todd A Florin, Jeffrey S Gerber, Michelle Gill, Debra L Palazzi, Mark Sawyer, Angela Statile, Derek J Williams, Sheena Patel, Mark I Neuman, Samir S Shah","doi":"10.1093/cid/ciag190","DOIUrl":"https://doi.org/10.1093/cid/ciag190","url":null,"abstract":"This paper is part of a larger clinical practice guideline on the diagnosis and management of parapneumonic effusion and empyema in children, developed by the Infectious Diseases Society of America. In this paper, the panel provides recommendations on the appropriate size of thoracostomy tube for drainage. The panel’s recommendations are based upon evidence derived from systematic literature reviews and adhere to a standardized methodology for rating the certainty of evidence and strength of recommendation according to the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) approach.","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":"32 1","pages":""},"PeriodicalIF":11.8,"publicationDate":"2026-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147465503","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Shawn D St. Peter, Krow Ampofo, Thomas Brogan, Michael D Cabana, Claudia Espinosa, Todd A Florin, Jeffrey S Gerber, Michelle Gill, Debra L Palazzi, Mark Sawyer, Angela M Statile, Derek J Williams, Sheena Patel, Samir S Shah, Mark I Neuman
This paper is part of a larger clinical practice guideline on the diagnosis and management of parapneumonic effusion and empyema in children, developed by the Pediatric Infectious Diseases Society and the Infectious Diseases Society of America. In this paper, the panel provides recommendations for the role of chest ultrasound to evaluate parapneumonic effusion and empyema. The panel’s recommendations are based upon evidence derived from systematic literature reviews and adhere to a standardized methodology for rating the certainty of evidence and strength of recommendation according to the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) approach.
{"title":"2026 Clinical Practice Guideline Update by the Infectious Diseases Society of America and the Pediatric Infectious Diseases Society on The Management of Community-Acquired Pneumonia in Infants and Children Older than 3 Months of Age: The Use of Chest Ultrasound in Children with Parapneumonic Effusion","authors":"Shawn D St. Peter, Krow Ampofo, Thomas Brogan, Michael D Cabana, Claudia Espinosa, Todd A Florin, Jeffrey S Gerber, Michelle Gill, Debra L Palazzi, Mark Sawyer, Angela M Statile, Derek J Williams, Sheena Patel, Samir S Shah, Mark I Neuman","doi":"10.1093/cid/ciag187","DOIUrl":"https://doi.org/10.1093/cid/ciag187","url":null,"abstract":"This paper is part of a larger clinical practice guideline on the diagnosis and management of parapneumonic effusion and empyema in children, developed by the Pediatric Infectious Diseases Society and the Infectious Diseases Society of America. In this paper, the panel provides recommendations for the role of chest ultrasound to evaluate parapneumonic effusion and empyema. The panel’s recommendations are based upon evidence derived from systematic literature reviews and adhere to a standardized methodology for rating the certainty of evidence and strength of recommendation according to the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) approach.","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":"107 1","pages":""},"PeriodicalIF":11.8,"publicationDate":"2026-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147465506","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Michael A Martin,Alexandra Blenkinsop,Michelle Moffa,Steven James Reynolds,Fred Nalugoda,Thomas C Quinn,Godfrey Kigozi,Robert Ssekubugu,Ravindra K Gupta,Nicholas E Grayson,George MacIntyre-Cockett,Joseph Kagaayi,Gertrude Nakigozi,Lucie Abeler-Dörner,Christophe Fraser,Oliver Ratmann,Aaron A R Tobian,Oliver Laeyendecker,Sikhulile Moyo,Caitlin E Kennedy,David Bonsall,Ronald Moses Galiwango,M Kate Grabowski
BACKGROUNDData on the population-scale impact of dolutegravir (DTG)-based HIV regimens in sub-Saharan Africa are extremely limited. We used data from a surveillance cohort in southern Uganda to assess viral suppression and antiretroviral (ART) resistance over 10-years alongside DTG scale-up.METHODSConsenting participants in the population-based Rakai Community Cohort Study between August 2011 and March 2023 aged 15-49 completed questionnaires and provided samples for HIV testing, viral load quantification, and viral deep-sequencing. We collected data on DTG-utilization at HIV care clinics. We estimated the prevalence of HIV suppression and ART resistance using robust Poisson regression. Bayesian logistic regression quantified associations between resistance and individual-level suppression across surveys.RESULTSAmong 8,781 people living with HIV (PLHIV), suppression increased from 57.1% (2014, 95% confidence interval [CI]: 55.4%-58.8%) to 90.3% (2022, 95%CI: 89.2%-91.4%). By 2020 84.4% (95%CI: 83.7%-85.2%) and 64.6% (95%CI: 63.9%-65.3%) of men and women on ART were on DTG. Among treatment-experienced viremic PLHIV, any intermediate/high resistance decreased from 51.1% (95%CI: 40.7%-64.2%, 2014) to 27.9% (95%CI: 21.3%-36.5%, 2022). Two of 258 (0.8%) 2022 participants harbored intermediate/high-level DTG resistance (inQ148R, inE138K, and inG140A). inS153Y (two-fold INSTI resistance) was observed in 23/306 (7.5%) of viremic individuals, with evidence of transmission. By 2022, NNRTI/NRTI resistance was not associated with a reduction in individual-level suppression (risk ratios: 1.15, 95%HPD: 0.93-1.39; 1.14, 0.86 - 1.42).CONCLUSIONSViral suppression increased during the DTG-transition with minimal emerging intermediate/high-level resistance. Falling resistance among treatment-experienced PLHIV underscores the role of ART adherence in reducing viremia. The emergence of inS153Y justifies continued surveillance.
{"title":"Patterns of HIV-1 viral load suppression and drug resistance during the dolutegravir transition: a population-based longitudinal study.","authors":"Michael A Martin,Alexandra Blenkinsop,Michelle Moffa,Steven James Reynolds,Fred Nalugoda,Thomas C Quinn,Godfrey Kigozi,Robert Ssekubugu,Ravindra K Gupta,Nicholas E Grayson,George MacIntyre-Cockett,Joseph Kagaayi,Gertrude Nakigozi,Lucie Abeler-Dörner,Christophe Fraser,Oliver Ratmann,Aaron A R Tobian,Oliver Laeyendecker,Sikhulile Moyo,Caitlin E Kennedy,David Bonsall,Ronald Moses Galiwango,M Kate Grabowski","doi":"10.1093/cid/ciag161","DOIUrl":"https://doi.org/10.1093/cid/ciag161","url":null,"abstract":"BACKGROUNDData on the population-scale impact of dolutegravir (DTG)-based HIV regimens in sub-Saharan Africa are extremely limited. We used data from a surveillance cohort in southern Uganda to assess viral suppression and antiretroviral (ART) resistance over 10-years alongside DTG scale-up.METHODSConsenting participants in the population-based Rakai Community Cohort Study between August 2011 and March 2023 aged 15-49 completed questionnaires and provided samples for HIV testing, viral load quantification, and viral deep-sequencing. We collected data on DTG-utilization at HIV care clinics. We estimated the prevalence of HIV suppression and ART resistance using robust Poisson regression. Bayesian logistic regression quantified associations between resistance and individual-level suppression across surveys.RESULTSAmong 8,781 people living with HIV (PLHIV), suppression increased from 57.1% (2014, 95% confidence interval [CI]: 55.4%-58.8%) to 90.3% (2022, 95%CI: 89.2%-91.4%). By 2020 84.4% (95%CI: 83.7%-85.2%) and 64.6% (95%CI: 63.9%-65.3%) of men and women on ART were on DTG. Among treatment-experienced viremic PLHIV, any intermediate/high resistance decreased from 51.1% (95%CI: 40.7%-64.2%, 2014) to 27.9% (95%CI: 21.3%-36.5%, 2022). Two of 258 (0.8%) 2022 participants harbored intermediate/high-level DTG resistance (inQ148R, inE138K, and inG140A). inS153Y (two-fold INSTI resistance) was observed in 23/306 (7.5%) of viremic individuals, with evidence of transmission. By 2022, NNRTI/NRTI resistance was not associated with a reduction in individual-level suppression (risk ratios: 1.15, 95%HPD: 0.93-1.39; 1.14, 0.86 - 1.42).CONCLUSIONSViral suppression increased during the DTG-transition with minimal emerging intermediate/high-level resistance. Falling resistance among treatment-experienced PLHIV underscores the role of ART adherence in reducing viremia. The emergence of inS153Y justifies continued surveillance.","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":"234 1","pages":""},"PeriodicalIF":11.8,"publicationDate":"2026-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147439300","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
BACKGROUNDThe effectiveness of contact precautions (CP) and active surveillance (AS) for preventing methicillin-resistant Staphylococcus aureus (MRSA) in acute care remains uncertain. Some studies suggest CP reduces MRSA spread, while others report limited benefit. The COVID-19 pandemic disrupted MRSA prevention practices in the VA, creating an opportunity to assess their impact on MRSA healthcare-associated infections (HAIs).METHODSWe studied 121 VA acute care hospitals from July 2020-June 2022. Facility practices (AS, CP for colonized [CPC], CP for infected [CPI]) were assessed via national surveys. Patient-level data identified MRSA HAIs (incident cultures ≥3 days post-admission). Secondary outcomes included sterile-site infections and 30-day post-discharge cultures. Associations between practices and HAI rates were estimated using Poisson, negative binomial, and mixed-effects Poisson regression, adjusting for baseline MRSA burden, COVID-19 admissions, culturing intensity, and hospital characteristics.RESULTSAmong 905,164 admissions, 1,708 incident MRSA cultures were identified. Many facilities suspended at least one prevention practice early in the pandemic, though most later reinstated them. In simpler models, discontinuation of AS, CPC, or CPI was associated with higher MRSA rates, but these associations were attenuated after adjustment for baseline burden. Mixed-effects models found no significant associations, and results were consistent across secondary outcomes.CONCLUSIONSDiscontinuation of MRSA prevention practices during the pandemic was not consistently linked to increased HAIs after accounting for baseline burden. Findings emphasize the role of facility-specific factors and modeling assumptions in evaluating infection control. Unmeasured pandemic-related practices (e.g., masking, PPE use) likely also influenced transmission, highlighting the need for flexible, context-sensitive, evidence-based infection prevention policies.
{"title":"Estimating changes in facility MRSA infection rates due to changes in MRSA precaution policy.","authors":"Karim Khader,Candace Haroldsen,Vanessa Stevens,Lindsay Visnovsky,Martin Evans,Loretta Simbartl,Brian McCauley,Matthew Samore,Michael Rubin","doi":"10.1093/cid/ciag176","DOIUrl":"https://doi.org/10.1093/cid/ciag176","url":null,"abstract":"BACKGROUNDThe effectiveness of contact precautions (CP) and active surveillance (AS) for preventing methicillin-resistant Staphylococcus aureus (MRSA) in acute care remains uncertain. Some studies suggest CP reduces MRSA spread, while others report limited benefit. The COVID-19 pandemic disrupted MRSA prevention practices in the VA, creating an opportunity to assess their impact on MRSA healthcare-associated infections (HAIs).METHODSWe studied 121 VA acute care hospitals from July 2020-June 2022. Facility practices (AS, CP for colonized [CPC], CP for infected [CPI]) were assessed via national surveys. Patient-level data identified MRSA HAIs (incident cultures ≥3 days post-admission). Secondary outcomes included sterile-site infections and 30-day post-discharge cultures. Associations between practices and HAI rates were estimated using Poisson, negative binomial, and mixed-effects Poisson regression, adjusting for baseline MRSA burden, COVID-19 admissions, culturing intensity, and hospital characteristics.RESULTSAmong 905,164 admissions, 1,708 incident MRSA cultures were identified. Many facilities suspended at least one prevention practice early in the pandemic, though most later reinstated them. In simpler models, discontinuation of AS, CPC, or CPI was associated with higher MRSA rates, but these associations were attenuated after adjustment for baseline burden. Mixed-effects models found no significant associations, and results were consistent across secondary outcomes.CONCLUSIONSDiscontinuation of MRSA prevention practices during the pandemic was not consistently linked to increased HAIs after accounting for baseline burden. Findings emphasize the role of facility-specific factors and modeling assumptions in evaluating infection control. Unmeasured pandemic-related practices (e.g., masking, PPE use) likely also influenced transmission, highlighting the need for flexible, context-sensitive, evidence-based infection prevention policies.","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":"198 1","pages":""},"PeriodicalIF":11.8,"publicationDate":"2026-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147439664","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"A Turning Point for Hepatitis C Care: Point-of-Care HCV RNA Authorization as a Critical First Step Towards Integrated Test-and-Treat Models in the United States.","authors":"Nathan W Furukawa,Saleem Kamili,Carolyn Wester","doi":"10.1093/cid/ciag174","DOIUrl":"https://doi.org/10.1093/cid/ciag174","url":null,"abstract":"","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":"315 1","pages":""},"PeriodicalIF":11.8,"publicationDate":"2026-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147439297","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jennifer R Havens,Shelly-Ann Fluker,Jonathan Schimmel,L Madeline McCrary,Lesley S Miller,Tomoko Udo,Yukari C Manabe,Anne Luetkemeyer,Greer Burkholder,Andrew M Moon,Cody A Chastain,Jennifer C Price,John Cafardi,Juan F Gallegos-Orozco,Brittany A Young,Jesse Young,Carlos Aparicio,Yu Song,Eric Lai,Gail E Louw
BACKGROUNDA major barrier to hepatitis C virus (HCV) elimination in the United States (U.S.) is the lack of a point-of-care (POC) test to confirm the presence of HCV RNA. The purpose of this clinical trial was to evaluate the performance of the Xpert® HCV test at CLIA-waived sites in the U.S.METHODSParticipants at risk and/or with signs/symptoms of HCV infection provided fingerstick blood that was tested on the Xpert® HCV test and venous blood tested using the cobas® HCV and Elecsys® Anti-HCV II tests. Fingerstick blood was collected at CLIA-waived sites by individuals self-trained on collection procedures.RESULTSParticipants (N=1279) were enrolled across 15 sites; 1015 (79.3%) were deemed eligible for further evaluation. Specimens from 985 (97.0%) participants with valid results for Xpert®, cobas and Elecsys were included in the performance analysis. The prevalence of HCV antibodies and HCV RNA was 34.6% and 12.4%, respectively. The Xpert® HCV test demonstrated a positive percent agreement (PPA) of 93.4% (95% CI: 87.6-96.6) and a negative percent agreement (NPA) of 99.8% (95% CI: 99.2-99.9) relative to the patient infected status (PIS).CONCLUSIONSData from this clinical trial showed that the Xpert® HCV test was sensitive, specific, and acceptable for use to detect HCV RNA in human EDTA fingerstick blood from individuals at risk and/or with signs/symptoms of HCV infection.
{"title":"Performance Evaluation of the Xpert® HCV test on Fingerstick Blood in a Prospective Observational Clinical Study at CLIA-Waived Sites in the United States.","authors":"Jennifer R Havens,Shelly-Ann Fluker,Jonathan Schimmel,L Madeline McCrary,Lesley S Miller,Tomoko Udo,Yukari C Manabe,Anne Luetkemeyer,Greer Burkholder,Andrew M Moon,Cody A Chastain,Jennifer C Price,John Cafardi,Juan F Gallegos-Orozco,Brittany A Young,Jesse Young,Carlos Aparicio,Yu Song,Eric Lai,Gail E Louw","doi":"10.1093/cid/ciag173","DOIUrl":"https://doi.org/10.1093/cid/ciag173","url":null,"abstract":"BACKGROUNDA major barrier to hepatitis C virus (HCV) elimination in the United States (U.S.) is the lack of a point-of-care (POC) test to confirm the presence of HCV RNA. The purpose of this clinical trial was to evaluate the performance of the Xpert® HCV test at CLIA-waived sites in the U.S.METHODSParticipants at risk and/or with signs/symptoms of HCV infection provided fingerstick blood that was tested on the Xpert® HCV test and venous blood tested using the cobas® HCV and Elecsys® Anti-HCV II tests. Fingerstick blood was collected at CLIA-waived sites by individuals self-trained on collection procedures.RESULTSParticipants (N=1279) were enrolled across 15 sites; 1015 (79.3%) were deemed eligible for further evaluation. Specimens from 985 (97.0%) participants with valid results for Xpert®, cobas and Elecsys were included in the performance analysis. The prevalence of HCV antibodies and HCV RNA was 34.6% and 12.4%, respectively. The Xpert® HCV test demonstrated a positive percent agreement (PPA) of 93.4% (95% CI: 87.6-96.6) and a negative percent agreement (NPA) of 99.8% (95% CI: 99.2-99.9) relative to the patient infected status (PIS).CONCLUSIONSData from this clinical trial showed that the Xpert® HCV test was sensitive, specific, and acceptable for use to detect HCV RNA in human EDTA fingerstick blood from individuals at risk and/or with signs/symptoms of HCV infection.","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":"52 1","pages":""},"PeriodicalIF":11.8,"publicationDate":"2026-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147439298","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jonathan D Baghdadi,Anthony D Harris,Lisa Pineles,Shatha Al-Shanqeeti,Danica Palacio,Drew W Charles,Emily Heil,Kimberly C Claeys,Jacqueline T Bork,Sarah Sommerkamp,R Gentry Wilkerson,Gerald Godwin,Mark E Sutherland,J Kristie Johnson,Daniel J Morgan
BACKGROUNDRespiratory illness is the most frequent reason for unnecessary antibiotic use among hospitalized adults. In randomized trials, procalcitonin and respiratory virus testing without guidance on test interpretation do not influence antibiotic decision-making.METHODSWe conducted a pragmatic, randomized, controlled trial of antimicrobial stewardship-guided test interpretation versus usual care among hospitalized adults receiving antibiotics for suspected respiratory infection with either low procalcitonin or positive respiratory virus testing at 2 hospitals. The intervention involved a templated note in the electronic health record interpreting test results in terms of the post-test probability of bacterial pneumonia and antibiotic decision-making. When probability of bacterial pneumonia was low, discontinuation of antibiotic therapy was recommended. The primary outcome was in-hospital antibiotic days of therapy.RESULTSBetween 1 November 2023 and 10 January 2025, 107 adults were enrolled, including 65% with low procalcitonin, 30% with positive respiratory virus testing, and 5% with both. The intervention decreased antibiotic use by an average of 4.1 in-hospital days of therapy (7.5 versus 11.6, P = .006). All respiratory antibiotics were discontinued within 5 days of initiation for 76% of intervention patients versus 49% with usual care (P = .004). Length of stay (5.5 days intervention versus 6.6 days usual care, P = .16) and 30-day readmission (7% intervention versus 19% usual care, P = .079) did not significantly differ between groups.CONCLUSIONSIn this proof-of-concept study, antimicrobial stewardship-guided interpretation of laboratory tests for viral infection using a simple template safely decreased unnecessary antibiotic use for hospitalized adults with community-acquired respiratory illness. Clinical Trial Registration. NCT05976581.
背景：在住院成人中，呼吸道疾病是导致不必要抗生素使用的最常见原因。在随机试验中，没有测试解释指导的降钙素原和呼吸道病毒检测不会影响抗生素的决策。方法：我们在两家医院进行了一项实用的、随机的、对照试验，比较了抗菌药物管理指导下的试验解释与常规护理的对比，这些住院成人因疑似呼吸道感染而接受抗生素治疗，无论是降钙素原低还是呼吸道病毒检测阳性。干预涉及电子健康记录中的模板注释，根据测试后细菌性肺炎的概率和抗生素决策来解释测试结果。当发生细菌性肺炎的可能性较低时，建议停用抗生素治疗。主要观察指标为住院抗生素治疗天数。结果在2023年11月1日至2025年1月10日期间，纳入107名成人，其中65%降钙素原低，30%呼吸道病毒检测阳性，5%两者均阳性。干预使抗生素使用平均减少4.1住院治疗天数（7.5 vs 11.6, P = 0.006）。76%的干预患者在开始治疗的5天内停用了所有呼吸道抗生素，而常规护理组为49% （P = 0.004）。住院时间（干预期5.5天，常规护理期6.6天，P = 0.16）和30天再入院（干预期7%，常规护理期19%，P = 0.079）两组间无显著差异。结论：在这项概念验证性研究中，使用简单模板对病毒感染的实验室检测进行抗菌药物管理指导，安全减少了社区获得性呼吸系统疾病住院成人患者不必要的抗生素使用。临床试验注册。NCT05976581。
{"title":"Using Probability of Community-Acquired Pneumonia to Tailor Antimicrobials Among Inpatients: A Pragmatic, Randomized Trial.","authors":"Jonathan D Baghdadi,Anthony D Harris,Lisa Pineles,Shatha Al-Shanqeeti,Danica Palacio,Drew W Charles,Emily Heil,Kimberly C Claeys,Jacqueline T Bork,Sarah Sommerkamp,R Gentry Wilkerson,Gerald Godwin,Mark E Sutherland,J Kristie Johnson,Daniel J Morgan","doi":"10.1093/cid/ciag126","DOIUrl":"https://doi.org/10.1093/cid/ciag126","url":null,"abstract":"BACKGROUNDRespiratory illness is the most frequent reason for unnecessary antibiotic use among hospitalized adults. In randomized trials, procalcitonin and respiratory virus testing without guidance on test interpretation do not influence antibiotic decision-making.METHODSWe conducted a pragmatic, randomized, controlled trial of antimicrobial stewardship-guided test interpretation versus usual care among hospitalized adults receiving antibiotics for suspected respiratory infection with either low procalcitonin or positive respiratory virus testing at 2 hospitals. The intervention involved a templated note in the electronic health record interpreting test results in terms of the post-test probability of bacterial pneumonia and antibiotic decision-making. When probability of bacterial pneumonia was low, discontinuation of antibiotic therapy was recommended. The primary outcome was in-hospital antibiotic days of therapy.RESULTSBetween 1 November 2023 and 10 January 2025, 107 adults were enrolled, including 65% with low procalcitonin, 30% with positive respiratory virus testing, and 5% with both. The intervention decreased antibiotic use by an average of 4.1 in-hospital days of therapy (7.5 versus 11.6, P = .006). All respiratory antibiotics were discontinued within 5 days of initiation for 76% of intervention patients versus 49% with usual care (P = .004). Length of stay (5.5 days intervention versus 6.6 days usual care, P = .16) and 30-day readmission (7% intervention versus 19% usual care, P = .079) did not significantly differ between groups.CONCLUSIONSIn this proof-of-concept study, antimicrobial stewardship-guided interpretation of laboratory tests for viral infection using a simple template safely decreased unnecessary antibiotic use for hospitalized adults with community-acquired respiratory illness. Clinical Trial Registration. NCT05976581.","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":"73 1","pages":""},"PeriodicalIF":11.8,"publicationDate":"2026-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147439299","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Shawn D St. Peter, Krow Ampofo, Thomas Brogan, Michael D Cabana, Claudia Espinosa, Todd A Florin, Jeffrey S Gerber, Michelle Gill, Debra L Palazzi, Mark Sawyer, Angela M Statile, Derek J Williams, Sheena Patel, Mark I Neuman, Samir S Shah
As the first part of an update to the clinical practice guideline on the management of community-acquired pneumonia in infants and children older than 3 months of age, we present six updated recommendations. The updated recommendations span the characterization and management of pneumonia with parapneumonic effusion. The panel’s recommendations are based on evidence derived from systematic literature reviews and adhere to a standardized methodology for rating the certainty of evidence and strength of recommendation according to the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) approach.
{"title":"Clinical Practice Guideline by the Infectious Diseases Society of America and the Pediatric Infectious Diseases Society: 2026 Guideline Update on The Management of Community-Acquired Pneumonia in Infants and Children Older than 3 Months of Age","authors":"Shawn D St. Peter, Krow Ampofo, Thomas Brogan, Michael D Cabana, Claudia Espinosa, Todd A Florin, Jeffrey S Gerber, Michelle Gill, Debra L Palazzi, Mark Sawyer, Angela M Statile, Derek J Williams, Sheena Patel, Mark I Neuman, Samir S Shah","doi":"10.1093/cid/ciag186","DOIUrl":"https://doi.org/10.1093/cid/ciag186","url":null,"abstract":"As the first part of an update to the clinical practice guideline on the management of community-acquired pneumonia in infants and children older than 3 months of age, we present six updated recommendations. The updated recommendations span the characterization and management of pneumonia with parapneumonic effusion. The panel’s recommendations are based on evidence derived from systematic literature reviews and adhere to a standardized methodology for rating the certainty of evidence and strength of recommendation according to the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) approach.","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":"38 1","pages":""},"PeriodicalIF":11.8,"publicationDate":"2026-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147465505","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
京公网安备 11010802042870号
京ICP备2023020795号-1
扫码关注我们
求助内容：
应助结果提醒方式：