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Antibiotic Prophylaxis in Infants with Grade III, IV, or V Vesicoureteral Reflux.
Morello, William; Baskin, Esra; Jankauskiene, Augustina; Yalcinkaya, Fatos; Zurowska, Aleksandra; Puccio, Giuseppe; Serafinelli, Jessica; La Manna, Angela; Krzemien, Grazyna; 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.
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  • Morello W; From the Pediatric Nephrology, Dialysis, and Transplant Unit (W.M., G.P., J.S., G.M.) and the Pediatric Urology Unit (D.G.M.), Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, and the Department of Clinical Sciences and Community Health, University of Milan (G.M.), Milan, the Department o
  • Baskin E; From the Pediatric Nephrology, Dialysis, and Transplant Unit (W.M., G.P., J.S., G.M.) and the Pediatric Urology Unit (D.G.M.), Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, and the Department of Clinical Sciences and Community Health, University of Milan (G.M.), Milan, the Department o
  • Jankauskiene A; From the Pediatric Nephrology, Dialysis, and Transplant Unit (W.M., G.P., J.S., G.M.) and the Pediatric Urology Unit (D.G.M.), Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, and the Department of Clinical Sciences and Community Health, University of Milan (G.M.), Milan, the Department o
  • Yalcinkaya F; From the Pediatric Nephrology, Dialysis, and Transplant Unit (W.M., G.P., J.S., G.M.) and the Pediatric Urology Unit (D.G.M.), Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, and the Department of Clinical Sciences and Community Health, University of Milan (G.M.), Milan, the Department o
  • Zurowska A; From the Pediatric Nephrology, Dialysis, and Transplant Unit (W.M., G.P., J.S., G.M.) and the Pediatric Urology Unit (D.G.M.), Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, and the Department of Clinical Sciences and Community Health, University of Milan (G.M.), Milan, the Department o
  • Puccio G; From the Pediatric Nephrology, Dialysis, and Transplant Unit (W.M., G.P., J.S., G.M.) and the Pediatric Urology Unit (D.G.M.), Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, and the Department of Clinical Sciences and Community Health, University of Milan (G.M.), Milan, the Department o
  • Serafinelli J; From the Pediatric Nephrology, Dialysis, and Transplant Unit (W.M., G.P., J.S., G.M.) and the Pediatric Urology Unit (D.G.M.), Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, and the Department of Clinical Sciences and Community Health, University of Milan (G.M.), Milan, the Department o
  • La Manna A; From the Pediatric Nephrology, Dialysis, and Transplant Unit (W.M., G.P., J.S., G.M.) and the Pediatric Urology Unit (D.G.M.), Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, and the Department of Clinical Sciences and Community Health, University of Milan (G.M.), Milan, the Department o
  • Krzemien G; From the Pediatric Nephrology, Dialysis, and Transplant Unit (W.M., G.P., J.S., G.M.) and the Pediatric Urology Unit (D.G.M.), Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, and the Department of Clinical Sciences and Community Health, University of Milan (G.M.), Milan, the Department o
  • Pennesi M; From the Pediatric Nephrology, Dialysis, and Transplant Unit (W.M., G.P., J.S., G.M.) and the Pediatric Urology Unit (D.G.M.), Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, and the Department of Clinical Sciences and Community Health, University of Milan (G.M.), Milan, the Department o
  • La Scola C; From the Pediatric Nephrology, Dialysis, and Transplant Unit (W.M., G.P., J.S., G.M.) and the Pediatric Urology Unit (D.G.M.), Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, and the Department of Clinical Sciences and Community Health, University of Milan (G.M.), Milan, the Department o
  • Becherucci F; From the Pediatric Nephrology, Dialysis, and Transplant Unit (W.M., G.P., J.S., G.M.) and the Pediatric Urology Unit (D.G.M.), Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, and the Department of Clinical Sciences and Community Health, University of Milan (G.M.), Milan, the Department o
  • Brugnara M; From the Pediatric Nephrology, Dialysis, and Transplant Unit (W.M., G.P., J.S., G.M.) and the Pediatric Urology Unit (D.G.M.), Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, and the Department of Clinical Sciences and Community Health, University of Milan (G.M.), Milan, the Department o
  • Yuksel S; From the Pediatric Nephrology, Dialysis, and Transplant Unit (W.M., G.P., J.S., G.M.) and the Pediatric Urology Unit (D.G.M.), Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, and the Department of Clinical Sciences and Community Health, University of Milan (G.M.), Milan, the Department o
  • Mekahli D; From the Pediatric Nephrology, Dialysis, and Transplant Unit (W.M., G.P., J.S., G.M.) and the Pediatric Urology Unit (D.G.M.), Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, and the Department of Clinical Sciences and Community Health, University of Milan (G.M.), Milan, the Department o
  • Chimenz R; From the Pediatric Nephrology, Dialysis, and Transplant Unit (W.M., G.P., J.S., G.M.) and the Pediatric Urology Unit (D.G.M.), Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, and the Department of Clinical Sciences and Community Health, University of Milan (G.M.), Milan, the Department o
  • De Palma D; From the Pediatric Nephrology, Dialysis, and Transplant Unit (W.M., G.P., J.S., G.M.) and the Pediatric Urology Unit (D.G.M.), Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, and the Department of Clinical Sciences and Community Health, University of Milan (G.M.), Milan, the Department o
  • Zucchetta P; From the Pediatric Nephrology, Dialysis, and Transplant Unit (W.M., G.P., J.S., G.M.) and the Pediatric Urology Unit (D.G.M.), Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, and the Department of Clinical Sciences and Community Health, University of Milan (G.M.), Milan, the Department o
  • Vajauskas D; From the Pediatric Nephrology, Dialysis, and Transplant Unit (W.M., G.P., J.S., G.M.) and the Pediatric Urology Unit (D.G.M.), Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, and the Department of Clinical Sciences and Community Health, University of Milan (G.M.), Milan, the Department o
  • Drozdz D; From the Pediatric Nephrology, Dialysis, and Transplant Unit (W.M., G.P., J.S., G.M.) and the Pediatric Urology Unit (D.G.M.), Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, and the Department of Clinical Sciences and Community Health, University of Milan (G.M.), Milan, the Department o
  • Szczepanska M; From the Pediatric Nephrology, Dialysis, and Transplant Unit (W.M., G.P., J.S., G.M.) and the Pediatric Urology Unit (D.G.M.), Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, and the Department of Clinical Sciences and Community Health, University of Milan (G.M.), Milan, the Department o
  • Caliskan S; From the Pediatric Nephrology, Dialysis, and Transplant Unit (W.M., G.P., J.S., G.M.) and the Pediatric Urology Unit (D.G.M.), Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, and the Department of Clinical Sciences and Community Health, University of Milan (G.M.), Milan, the Department o
  • Lombet J; From the Pediatric Nephrology, Dialysis, and Transplant Unit (W.M., G.P., J.S., G.M.) and the Pediatric Urology Unit (D.G.M.), Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, and the Department of Clinical Sciences and Community Health, University of Milan (G.M.), Milan, the Department o
  • Minoli DG; From the Pediatric Nephrology, Dialysis, and Transplant Unit (W.M., G.P., J.S., G.M.) and the Pediatric Urology Unit (D.G.M.), Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, and the Department of Clinical Sciences and Community Health, University of Milan (G.M.), Milan, the Department o
  • Guarino S; From the Pediatric Nephrology, Dialysis, and Transplant Unit (W.M., G.P., J.S., G.M.) and the Pediatric Urology Unit (D.G.M.), Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, and the Department of Clinical Sciences and Community Health, University of Milan (G.M.), Milan, the Department o
  • Gulleroglu K; From the Pediatric Nephrology, Dialysis, and Transplant Unit (W.M., G.P., J.S., G.M.) and the Pediatric Urology Unit (D.G.M.), Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, and the Department of Clinical Sciences and Community Health, University of Milan (G.M.), Milan, the Department o
  • Ruzgiene D; From the Pediatric Nephrology, Dialysis, and Transplant Unit (W.M., G.P., J.S., G.M.) and the Pediatric Urology Unit (D.G.M.), Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, and the Department of Clinical Sciences and Community Health, University of Milan (G.M.), Milan, the Department o
  • Szmigielska A; From the Pediatric Nephrology, Dialysis, and Transplant Unit (W.M., G.P., J.S., G.M.) and the Pediatric Urology Unit (D.G.M.), Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, and the Department of Clinical Sciences and Community Health, University of Milan (G.M.), Milan, the Department o
  • Barbi E; From the Pediatric Nephrology, Dialysis, and Transplant Unit (W.M., G.P., J.S., G.M.) and the Pediatric Urology Unit (D.G.M.), Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, and the Department of Clinical Sciences and Community Health, University of Milan (G.M.), Milan, the Department o
  • Ozcakar ZB; From the Pediatric Nephrology, Dialysis, and Transplant Unit (W.M., G.P., J.S., G.M.) and the Pediatric Urology Unit (D.G.M.), Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, and the Department of Clinical Sciences and Community Health, University of Milan (G.M.), Milan, the Department o
  • Kranz A; From the Pediatric Nephrology, Dialysis, and Transplant Unit (W.M., G.P., J.S., G.M.) and the Pediatric Urology Unit (D.G.M.), Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, and the Department of Clinical Sciences and Community Health, University of Milan (G.M.), Milan, the Department o
  • Pasini A; From the Pediatric Nephrology, Dialysis, and Transplant Unit (W.M., G.P., J.S., G.M.) and the Pediatric Urology Unit (D.G.M.), Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, and the Department of Clinical Sciences and Community Health, University of Milan (G.M.), Milan, the Department o
  • Materassi M; From the Pediatric Nephrology, Dialysis, and Transplant Unit (W.M., G.P., J.S., G.M.) and the Pediatric Urology Unit (D.G.M.), Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, and the Department of Clinical Sciences and Community Health, University of Milan (G.M.), Milan, the Department o
  • De Rechter S; From the Pediatric Nephrology, Dialysis, and Transplant Unit (W.M., G.P., J.S., G.M.) and the Pediatric Urology Unit (D.G.M.), Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, and the Department of Clinical Sciences and Community Health, University of Milan (G.M.), Milan, the Department o
  • Ariceta G; From the Pediatric Nephrology, Dialysis, and Transplant Unit (W.M., G.P., J.S., G.M.) and the Pediatric Urology Unit (D.G.M.), Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, and the Department of Clinical Sciences and Community Health, University of Milan (G.M.), Milan, the Department o
  • Weber LT; From the Pediatric Nephrology, Dialysis, and Transplant Unit (W.M., G.P., J.S., G.M.) and the Pediatric Urology Unit (D.G.M.), Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, and the Department of Clinical Sciences and Community Health, University of Milan (G.M.), Milan, the Department o
  • Marzuillo P; From the Pediatric Nephrology, Dialysis, and Transplant Unit (W.M., G.P., J.S., G.M.) and the Pediatric Urology Unit (D.G.M.), Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, and the Department of Clinical Sciences and Community Health, University of Milan (G.M.), Milan, the Department o
  • Alberici I; From the Pediatric Nephrology, Dialysis, and Transplant Unit (W.M., G.P., J.S., G.M.) and the Pediatric Urology Unit (D.G.M.), Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, and the Department of Clinical Sciences and Community Health, University of Milan (G.M.), Milan, the Department o
  • Taranta-Janusz K; From the Pediatric Nephrology, Dialysis, and Transplant Unit (W.M., G.P., J.S., G.M.) and the Pediatric Urology Unit (D.G.M.), Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, and the Department of Clinical Sciences and Community Health, University of Milan (G.M.), Milan, the Department o
  • Caldas Afonso A; From the Pediatric Nephrology, Dialysis, and Transplant Unit (W.M., G.P., J.S., G.M.) and the Pediatric Urology Unit (D.G.M.), Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, and the Department of Clinical Sciences and Community Health, University of Milan (G.M.), Milan, the Department o
  • Tkaczyk M; From the Pediatric Nephrology, Dialysis, and Transplant Unit (W.M., G.P., J.S., G.M.) and the Pediatric Urology Unit (D.G.M.), Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, and the Department of Clinical Sciences and Community Health, University of Milan (G.M.), Milan, the Department o
  • Català M; From the Pediatric Nephrology, Dialysis, and Transplant Unit (W.M., G.P., J.S., G.M.) and the Pediatric Urology Unit (D.G.M.), Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, and the Department of Clinical Sciences and Community Health, University of Milan (G.M.), Milan, the Department o
  • Cabrera Sevilla JE; From the Pediatric Nephrology, Dialysis, and Transplant Unit (W.M., G.P., J.S., G.M.) and the Pediatric Urology Unit (D.G.M.), Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, and the Department of Clinical Sciences and Community Health, University of Milan (G.M.), Milan, the Department o
  • Mehls O; From the Pediatric Nephrology, Dialysis, and Transplant Unit (W.M., G.P., J.S., G.M.) and the Pediatric Urology Unit (D.G.M.), Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, and the Department of Clinical Sciences and Community Health, University of Milan (G.M.), Milan, the Department o
  • Schaefer F; From the Pediatric Nephrology, Dialysis, and Transplant Unit (W.M., G.P., J.S., G.M.) and the Pediatric Urology Unit (D.G.M.), Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, and the Department of Clinical Sciences and Community Health, University of Milan (G.M.), Milan, the Department o
  • Montini G; From the Pediatric Nephrology, Dialysis, and Transplant Unit (W.M., G.P., J.S., G.M.) and the Pediatric Urology Unit (D.G.M.), Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, and the Department of Clinical Sciences and Community Health, University of Milan (G.M.), Milan, the Department o
N Engl J Med ; 389(11): 987-997, 2023 Sep 14.
Article en En | MEDLINE | ID: mdl-37702442
BACKGROUND: The efficacy of continuous antibiotic prophylaxis in preventing urinary tract infection (UTI) in infants with grade III, IV, or V vesicoureteral reflux is controversial. METHODS: In 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. RESULTS: A 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. CONCLUSIONS: In 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.).
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Contexto en salud: 1_ASSA2030 Problema de salud: 1_doencas_nao_transmissiveis Asunto principal: Infecciones Urinarias / Reflujo Vesicoureteral / Profilaxis Antibiótica / Antibacterianos Tipo de estudio: Clinical_trials / Etiology_studies / Prognostic_studies Límite: Female / Humans / Infant / Male Idioma: En Revista: N Engl J Med Año: 2023 Tipo del documento: Article
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Contexto en salud: 1_ASSA2030 Problema de salud: 1_doencas_nao_transmissiveis Asunto principal: Infecciones Urinarias / Reflujo Vesicoureteral / Profilaxis Antibiótica / Antibacterianos Tipo de estudio: Clinical_trials / Etiology_studies / Prognostic_studies Límite: Female / Humans / Infant / Male Idioma: En Revista: N Engl J Med Año: 2023 Tipo del documento: Article