Does acute pyelonephritis skew outcomes in registrational trials of novel antibiotics for complicated urinary tract infections? A systematic review and meta-analysis
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Le résumé fourni par la source
BACKGROUND: Acute pyelonephritis (AP) and complicated urinary tract infections (cUTIs) are pooled in registrational RCTs of new antibiotics. We assessed whether outcomes differ between subtypes and which component of the composite endpoint drives any difference. METHODS: Across ten registrational RCTs we estimated the AP-versus-cUTI treatment effect on the composite primary endpoint (clinical cure plus microbiologic eradication at test-of-cure) using random-effects risk ratios, with risk-difference, odds-ratio and leave-one-out sensitivity analyses. Between-arm differences in the composite and its components were correlated across trials; operative definitions and stratified-reporting practices were extracted. RESULTS: From 5,971 patients (3,393 AP; 2,578 other cUTI), AP showed higher overall cure at TOC (pooled RR=1.12; 95% CI 1.03-1.23; I2=82%; 95% prediction interval 0.86-1.46). Between-arm differences in the composite correlated strongly with those in microbiologic eradication (r=0.98) but only weakly with those in clinical cure (r=0.30). In the single trial reporting components stratified by infection subtype (ADAPT-PO), the AP-versus-cUTI gap was larger in microbiologic eradication (+15.6 pp) than in clinical response (+3.5 pp); whether this pattern generalizes to the remaining nine trials could not be publicly tested. Risk of bias was overall some concerns in nine of ten trials, mostly for missing outcome data and selection of the reported result. CONCLUSIONS: AP achieved higher cure rates at TOC than other cUTIs. Heterogeneity in operative AP/cUTI definitions and limited stratified reporting of component outcomes reduce interstudy comparability. Future trials should harmonize definitions, prespecify stratification by infection subtype, and disclose clinical and microbiologic outcomes separately.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Does acute pyelonephritis skew outcomes in registrational trials of novel antibiotics for complicated urinary tract infections? A systematic review and meta-analysis
- Date Crossref
- 27/08/2026
- Éditeur
- Oxford University Press (OUP)
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Ospedale Santa Chiara pays non établi dans la noticeÉtablissement de santé
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University of Udine Department of Medicine (DMED) pays non établi dans la noticeUniversité ou école supérieure
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University of Catania Department of Biomedical and Biotechnological Sciences pays non établi dans la noticeUniversité ou école supérieure
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University of Trento Interdepartmental Centre of Medical Sciences (CISMed) pays non établi dans la noticeUniversité ou école supérieure
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Oslo University Hospital Department of Urology pays non établi dans la noticeÉtablissement de santé
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University of Oslo Institute of Clinical Medicine pays non établi dans la noticeUniversité ou école supérieure
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Aarhus University Hospital pays non établi dans la noticeÉtablissement de santé
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Santa Chiara Regional and Teaching Hospital Infectious Disease Unit pays non établi dans la noticeÉtablissement de santé
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University of Aarhus Institute of Clinical Medicine pays non établi dans la noticeUniversité ou école supérieure
Ospedale Santa Chiara, Department of Medicine (DMED) — University of Udine et Department of Biomedical and Biotechnological Sciences — University of Catania, avec 6 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.