Please use this identifier to cite or link to this item: 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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