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https://hdl.handle.net/11499/54982
Title: | Antibiotic Prophylaxis in Infants with Grade III, IV, or V Vesicoureteral Reflux | Authors: | Morello, William Basküın, Esra Jankauskiene, Augustina Yalçınkaya, Fatoş Zurowska, Aleksandra Puccio, Giuseppe Serafinelli, Jessica La Manna, Angela Krzemień, Grażyna Pennesi, Marco La Scola, Claudio Becherucci, Francesca Brugnara, Milena Yuksel, Selcuk Mekahli, Djalila Chimenz, Roberto De Palma, Diego Zucchetta, Pietro Vajauskas, Donatas Drozdz, Dorota Szczepanska, Maria Caliskan, Salim Lombet, Jacques Minoli, Dario G. Guarino, Stefano Gulleroglu, Kaan Ruzgiene, Dovile Szmigielska, Agnieszka Barbi, Egidio Ozcakar, Zeynep B. Kranz, Anna Pasini, Andrea Materassi, Marco De Rechter, Stephanie Ariceta, Gema Weber, Lutz T. Marzuillo, Pierluigi Alberici, Irene Taranta-Janusz, Katarzyna Caldas Afonso, Alberto Tkaczyk, Marcin Català, Margarita Cabrera Sevilla, Jose E. Mehls, Otto Schaefer, Franz Montini, Giovanni |
Keywords: | Urinary-Tract-Infections Children Management |
Publisher: | Massachusetts Medical Soc | Abstract: | BackgroundThe efficacy of continuous antibiotic prophylaxis in preventing urinary tract infection (UTI) in infants with grade III, IV, or V vesicoureteral reflux is controversial.MethodsIn this investigator-initiated, randomized, open-label trial performed in 39 European centers, we randomly assigned infants 1 to 5 months of age with grade III, IV, or V vesicoureteral reflux and no previous UTIs to receive continuous antibiotic prophylaxis (prophylaxis group) or no treatment (untreated group) for 24 months. The primary outcome was the occurrence of the first UTI during the trial period. Secondary outcomes included new kidney scarring and the estimated glomerular filtration rate (GFR) at 24 months.ResultsA total of 292 participants underwent randomization (146 per group). Approximately 75% of the participants were male; the median age was 3 months, and 235 participants (80.5%) had grade IV or V vesicoureteral reflux. In the intention-to-treat analysis, a first UTI occurred in 31 participants (21.2%) in the prophylaxis group and in 52 participants (35.6%) in the untreated group (hazard ratio, 0.55; 95% confidence interval [CI], 0.35 to 0.86; P=0.008); the number needed to treat for 2 years to prevent one UTI was 7 children (95% CI, 4 to 29). Among untreated participants, 64.4% had no UTI during the trial. The incidence of new kidney scars and the estimated GFR at 24 months did not differ substantially between the two groups. Pseudomonas species, other non-Escherichia coli organisms, and antibiotic resistance were more common in UTI isolates obtained from participants in the prophylaxis group than in isolates obtained from those in the untreated group. Serious adverse events were similar in the two groups.ConclusionsIn infants with grade III, IV, or V vesicoureteral reflux and no previous UTIs, continuous antibiotic prophylaxis provided a small but significant benefit in preventing a first UTI despite an increased occurrence of non-E. coli organisms and antibiotic resistance. (Funded by the Italian Ministry of Health and others; PREDICT ClinicalTrials.gov number, NCT02021006; EudraCT number, 2013-000309-21.) In a trial involving infants with grade III, IV, or V vesicoureteral reflux and no previous UTI, continuous antibiotic prophylaxis for 2 years provided a small but significant benefit in preventing a first UTI. | Description: | Article; Early Access | URI: | https://doi.org/10.1056/NEJMoa2300161 https://hdl.handle.net/11499/54982 |
ISSN: | 0028-4793 1533-4406 |
Appears in Collections: | PubMed İndeksli Yayınlar Koleksiyonu / PubMed Indexed Publications Collection Scopus İndeksli Yayınlar Koleksiyonu / Scopus Indexed Publications Collection Tıp Fakültesi Koleksiyonu WoS İndeksli Yayınlar Koleksiyonu / WoS Indexed Publications Collection |
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