David Alexanderian, Fabiano Ramos, Soumya Chatterjee, Alexandre Vargas Schwarzbold, Ana Paula Loch, Ariane Cristina Barboza Zanetti, Qiuxu Chen, Jason Martin, Matthew T Onorato, Germán Áñez
{"title":"Safety and Immunogenicity of the Live-Attenuated Quadrivalent Dengue Vaccine V181 Compared With Butantan-DV Among Healthy Adults in Brazil: A Randomized, Double-Blind, Phase 2 Trial.","authors":"David Alexanderian, Fabiano Ramos, Soumya Chatterjee, Alexandre Vargas Schwarzbold, Ana Paula Loch, Ariane Cristina Barboza Zanetti, Qiuxu Chen, Jason Martin, Matthew T Onorato, Germán Áñez","doi":"10.1093/cid/ciag349","DOIUrl":"10.1093/cid/ciag349","url":null,"abstract":"<p><strong>Background: </strong>Dengue is caused by infection with 1 of 4 dengue virus (DENV) serotypes (DENV-1 to DENV-4). V181 and Butantan-Dengue Vaccine (Butantan-DV) are independently developed, single-dose, quadrivalent dengue vaccines based on the same attenuated parental strains.</p><p><strong>Methods: </strong>In this randomized, double-blind, active comparator-controlled, multisite, phase 2 trial, we compared the safety and immunogenicity of V181 and Butantan-DV in healthy adults in Brazil. The primary immunogenicity objectives were to compare vaccine-induced neutralizing antibody geometric mean titers (GMTs) and seroconversion rates for DENV-1 to DENV-4 at day 28 postvaccination. The primary and secondary safety objectives, respectively, were to assess vaccine-related serious adverse events and the proportion of participants experiencing solicited adverse events through day 28 postvaccination.</p><p><strong>Results: </strong>Overall, 1364 participants were assigned (1:1) to receive V181 (n = 682) or Butantan-DV (n = 682). At day 28 postvaccination, V181 induced a noninferior immune response to Butantan-DV for DENV-1 and DENV-2 but not DENV-3 and DENV-4, as measured using GMT ratios. Noninferiority was established for all DENV serotypes based on seroconversion rates. Most participants developed a trivalent or tetravalent neutralizing antibody response. Vaccine viremia was detected for each DENV serotype. V181 and Butantan-DV were generally well tolerated.</p><p><strong>Conclusions: </strong>V181 was immunogenic in adults, and while immunogenicity was noninferior to Butantan-DV for DENV-1 and DENV-2, seroconversion rates were noninferior for DENV-1 to DENV-4. The safety profile of V181 is comparable to that of Butantan-DV and supports its continued evaluation as a single-dose quadrivalent vaccine for dengue prevention.</p><p><strong>Clinical trials registration: </strong>NCT05710224.</p>","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":" ","pages":"e629-e638"},"PeriodicalIF":8.3,"publicationDate":"2026-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13644855/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148359848","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Decoding AXR: Separating Signal From Noise in Outpatient Antibiotic Stewardship.","authors":"Marisa Holubar, David Ha","doi":"10.1093/cid/ciag256","DOIUrl":"10.1093/cid/ciag256","url":null,"abstract":"","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":" ","pages":"362-363"},"PeriodicalIF":8.3,"publicationDate":"2026-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148148640","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}
Alison G C Smith, Audrey Valentine, Marisa D'Angeli, Audrey Brezak, Emily Spence Davizon, Vanessa A Makarewicz, Jennifer Morgan, Julie Loughran, Alexander L Greninger, Lori Bourassa, Krista Rietberg, Nathanael Napolitano, Bonnie MacLeod, Kelly Kauber, John B Lynch, Eric J Chow, Chloe Bryson-Cahn
{"title":"Enhanced Detection of Candidozyma auris Colonization With Universal Screening on Admission.","authors":"Alison G C Smith, Audrey Valentine, Marisa D'Angeli, Audrey Brezak, Emily Spence Davizon, Vanessa A Makarewicz, Jennifer Morgan, Julie Loughran, Alexander L Greninger, Lori Bourassa, Krista Rietberg, Nathanael Napolitano, Bonnie MacLeod, Kelly Kauber, John B Lynch, Eric J Chow, Chloe Bryson-Cahn","doi":"10.1093/cid/ciag351","DOIUrl":"10.1093/cid/ciag351","url":null,"abstract":"<p><p>Universal admission screening for Candidozyma auris (C. auris) identified C. auris colonization in 25/22742 (0.1%) of patients. Most patients (20/25, 80%) did not meet public health screening criteria, suggesting known risk factors for C. auris may not sufficiently capture the impacted population. Findings may not be generalizable to higher-incidence settings.</p>","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":" ","pages":"438-441"},"PeriodicalIF":8.3,"publicationDate":"2026-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148204428","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 Road Not Yet Taken: Cell-Free DNA Polymerase Chain Reaction Testing for Coccidioidomycosis.","authors":"Fariba M Donovan","doi":"10.1093/cid/ciag288","DOIUrl":"10.1093/cid/ciag288","url":null,"abstract":"","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":" ","pages":"436-437"},"PeriodicalIF":8.3,"publicationDate":"2026-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147834546","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":"Does the DOOR Account for Post-randomization Treatment Modification or Incorporate It?","authors":"Praveen Kumar Tirlangi,Nitin Gupta","doi":"10.1093/cid/ciag626","DOIUrl":"https://doi.org/10.1093/cid/ciag626","url":null,"abstract":"Summary This correspondence clarifies that DOOR incorporates, rather than causally accounts for, post-randomization treatment modification. In the voriconazole–amphotericin B trial, frequent treatment switching means the reported DOOR probability reflects treatment strategies as implemented, not sustained randomized monotherapy throughout the original trial.","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":"34 1","pages":""},"PeriodicalIF":11.8,"publicationDate":"2026-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149089532","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}
Nicholas S Britt, Karim Khader, Tao He, Andrea M Prinzi, Benjamin Hommel, Tristan T Timbrook, Emily M Potter, Thomas P Lodise
{"title":"Clinical Impact of the BIOFIRE® FILMARRAY® Pneumonia Panel in the Veterans Affairs Healthcare System: A Difference-in-Differences Study.","authors":"Nicholas S Britt, Karim Khader, Tao He, Andrea M Prinzi, Benjamin Hommel, Tristan T Timbrook, Emily M Potter, Thomas P Lodise","doi":"10.1093/cid/ciag328","DOIUrl":"10.1093/cid/ciag328","url":null,"abstract":"<p><strong>Background: </strong>Rapid diagnostics such as the BIOFIRE® FILMARRAY® Pneumonia (PN) Panel may enhance antibiotic optimization, yet real-world evidence remains limited, and few studies have assessed how differences in institutional antimicrobial stewardship (ASP) capacity influence clinical outcomes.</p><p><strong>Methods: </strong>We conducted a national, multicenter retrospective study of ICU patients with pneumonia admitted to Veterans Health Administration hospitals. Hospitals that implemented the PN Panel for ≥6 months served as intervention sites, while matched facilities without implementation served as controls. Outcomes were assessed using a difference-in-differences framework with inverse probability weighting to account for baseline imbalances and secular trends, including those related to the COVID-19 pandemic. Co-primary outcomes, assessed following index culture collection, were early antimicrobial de-escalation (24-48 hours) and early appropriate therapy (0-24 hours); secondary outcomes were 30-day and ICU mortality.</p><p><strong>Results: </strong>The study included 11 746 patients, including 4523 from hospitals that implemented the BIOFIRE® PN Panel and 7223 from matched control hospitals. Overall, PN implementation was associated with early antimicrobial de-escalation (adjusted RR [aRR], 1.14; 95% CI, 1.04-1.26). Among culture-positive patients, PN Panel implementation was significantly associated with early antimicrobial de-escalation (aRR, 1.23; 95% CI, 1.02-1.50) and early appropriate therapy (aRR, 1.11; 95% CI, 1.04-1.18). Overall ICU and 30-day mortality did not differ, though ICU mortality among culture-positive patients was relatively lower following PN Panel implementation (aRR, .70; 95% CI, 0.50-0.97). Improvements in antimicrobial optimization were most evident in hospitals with greater ASP capacity.</p><p><strong>Conclusions: </strong>BIOFIRE® PN Panel implementation improved antibiotic optimization in critically ill pneumonia patients, with the greatest gains seen in hospitals with comprehensive ASP programs.</p>","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":" ","pages":"e461-e471"},"PeriodicalIF":8.3,"publicationDate":"2026-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13644875/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148223577","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jun-Won Seo, Da Young Kim, Youngmin Yoon, Young Sang Lyu, Yong Sub Na, Do Sik Moon, Na Ra Yun, Min Seok Kim, Jeong-Han Kim, Sang Woon Bae, Jian Hur, Min Hyung Kim, Yoon Soo Park, Heejung Kim, Hyungdon Lee, Younggwon On, Seok Hyeon Na, Jung Sik Yoo, Hee-Chang Jang, Dong-Min Kim
{"title":"Fosfomycin as Oral Transition Therapy Versus Continued Intravenous β-Lactams for Complicated Urinary Tract Infections Caused by Extended-Spectrum β-Lactamase-Producing Enterobacterales: A Multicenter, Open-Label, Randomized Controlled Trial.","authors":"Jun-Won Seo, Da Young Kim, Youngmin Yoon, Young Sang Lyu, Yong Sub Na, Do Sik Moon, Na Ra Yun, Min Seok Kim, Jeong-Han Kim, Sang Woon Bae, Jian Hur, Min Hyung Kim, Yoon Soo Park, Heejung Kim, Hyungdon Lee, Younggwon On, Seok Hyeon Na, Jung Sik Yoo, Hee-Chang Jang, Dong-Min Kim","doi":"10.1093/cid/ciag345","DOIUrl":"10.1093/cid/ciag345","url":null,"abstract":"<p><strong>Background: </strong>Extended-spectrum β-lactamase (ESBL)-producing Enterobacterales are an increasing cause of complicated urinary tract infections (UTIs). Reliance on carbapenems to treat these infections accelerates resistance, underscoring the urgent need for effective oral transition options to preserve last-line agents and lessen healthcare burden.</p><p><strong>Methods: </strong>We conducted a multicenter, open-label, randomized, noninferiority trial at four tertiary hospitals in South Korea (November 2022-June 2025). Adults hospitalized with complicated UTIs due to ESBL-producing Enterobacterales who improved after 3-7 days of intravenous antibiotics were randomized (1:1) to either continue intravenous carbapenem or β-lactam/β-lactamase inhibitor therapy or switch to oral fosfomycin trometamol (3 g once daily). The primary outcome was clinical cure, defined as resolution of urinary tract infection-related symptoms and signs within 4 days after completion of treatment. Secondary outcomes included microbiological cure, readmission, adverse events, and 30-day recurrence.</p><p><strong>Results: </strong>Of the 344 screened patients, 299 were randomized (152 oral fosfomycin; 147 intravenous therapy). Clinical cure occurred in 92.8% of the oral fosfomycin group and 95.2% of the intravenous group (risk difference, -2.47%; 95% CI -7.84 to 2.89), confirming noninferiority. Microbiological cure was similarly high in both groups: urine (98.0% vs 96.6%) and blood (97.3% vs 97.5%). Safety profiles and 30-day outcomes were also comparable.</p><p><strong>Conclusions: </strong>Oral fosfomycin was noninferior to continued intravenous therapy when used as oral transition therapy for complicated UTIs caused by ESBL-producing Enterobacterales. These findings provide evidence to support oral fosfomycin transition as a carbapenem-sparing antibiotic stewardship strategy for patients with complicated UTIs caused by ESBL-producing Enterobacterales.</p><p><strong>Clinical trials registration: </strong>KCT0007669.</p>","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":" ","pages":"364-372"},"PeriodicalIF":8.3,"publicationDate":"2026-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148270603","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":"Correction to: Clinical Impact of the BIOFIRE® FILMARRAY® Pneumonia Panel in the Veterans Affairs Healthcare System: A Difference-in-Differences Study.","authors":"","doi":"10.1093/cid/ciag380","DOIUrl":"10.1093/cid/ciag380","url":null,"abstract":"","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":" ","pages":"e688"},"PeriodicalIF":8.3,"publicationDate":"2026-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13644872/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148293615","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Early Combination Therapy for Methicillin-Resistant Staphylococcus aureus Bacteremia: Double Coverage or Double Trouble?","authors":"Sarah B Doernberg, Thomas L Holland","doi":"10.1093/cid/ciag229","DOIUrl":"10.1093/cid/ciag229","url":null,"abstract":"","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":" ","pages":"388-390"},"PeriodicalIF":8.3,"publicationDate":"2026-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148204444","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":"Efficacy Is Not Enough: Delivering Tuberculosis Preventive Therapy in the Real World.","authors":"Simone E Barry","doi":"10.1093/cid/ciag307","DOIUrl":"10.1093/cid/ciag307","url":null,"abstract":"","PeriodicalId":10463,"journal":{"name":"Clinical Infectious Diseases","volume":" ","pages":"e548-e549"},"PeriodicalIF":8.3,"publicationDate":"2026-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147927211","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}