• William Morello, Esra Baskin, Augustina Jankauskiene, Fatos Yalcinkaya, Aleksandra Zurowska, Giuseppe Puccio, Jessica Serafinelli, Angela La Manna, Grażyna Krzemień, Marco Pennesi, Claudio La Scola, Francesca Becherucci, Milena Brugnara, Selcuk Yuksel, Djalila Mekahli, Roberto Chimenz, Diego De Palma, Pietro Zucchetta, Donatas Vajauskas, Dorota Drozdz, Maria Szczepanska, Salim Caliskan, Jacques Lombet, Dario G Minoli, Stefano Guarino, Kaan Gulleroglu, Dovile Ruzgiene, Agnieszka Szmigielska, Egidio Barbi, Zeynep B Ozcakar, Anna Kranz, Andrea Pasini, Marco Materassi, Stephanie De Rechter, Gema Ariceta, Lutz T Weber, Pierluigi Marzuillo, Irene Alberici, Katarzyna Taranta-Janusz, Alberto Caldas Afonso, Marcin Tkaczyk, Margarita Català, Jose E Cabrera Sevilla, Otto Mehls, Franz Schaefer, Giovanni Montini, and PREDICT Study Group.
• 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 of General and Specialized Surgery for Women and Children, Università degli Studi della Campania "Luigi Vanvitelli," Naples (A.L.M., S.G., P.M.), the Institute for Maternal and Child Health-IRCCS Burlo Garofolo (M.P., E. Barbi) and the Department of Medical, Surgical, and Health Sciences, University of Trieste (E. Barbi), Trieste, Pediatric Nephrology and Dialysis, Pediatric Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna (C.L.S., A.P.), the Nephrology and Dialysis Unit, Meyer Children's Hospital, Florence (F.B., M.M.), Pediatria C, Ospedale Donna Bambino, Verona (M.B.), the Pediatric Nephrology and Rheumatology Unit, Azienda Ospedaliera Universitaria Gaetano Martino, University of Messina, Messina (R.C.), the Nuclear Medicine Unit, Circolo Hospital and Macchi Foundation, Azienda Socio Sanitaria Territoriale Sette Laghi, Varese (D.D.P.), the Nuclear Medicine Unit, Department of Medicine, University Hospital of Padua (P.Z.), and the Pediatric Nephrology, Dialysis, and Transplantation Unit, Department of Women's and Children's Health, University of Padua (I.A.), Padua - all in Italy; the Department of Pediatric Nephrology, Başkent University Faculty of Medicine (E. Baskin, K.G.), and the Department of Pediatric Nephrology, Ankara University School of Medicine (F.Y., Z.B.O.), Ankara, the Department of Pediatric Nephrology and Pediatric Rheumatology, Pamukkale University School of Medicine, Denizli (S.Y.), and the Department of Pediatric Nephrology, Istanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, Istanbul (S.C.) - all in Turkey; the Pediatric Center, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Vilnius (A.J., D.R.), and the Department of Radiology, Medical Academy, Lithuanian University of Health Sciences Kauno Klinikos, Kaunas (D.V.) - both in Lithuania; the Department of Pediatrics, Nephrology, and Hypertension, Medical University of Gdansk, Gdansk (A.Z., A.K.), the Department of Pediatrics and Nephrology, Medical University of Warsaw, Warsaw (G.K., A.S.), the Department of Pediatric Nephrology and Hypertension, Chair of Pediatrics, Pediatric Institute, Jagiellonian University Medical College, Krakow (D.D.), the Department of Pediatrics, Faculty of Medical Sciences in Zabrze, Medical University of Silesia in Katowice, Katowice (M.S.), the Department of Pediatrics and Nephrology, Medical University of Bialystok, Bialystok (K.T.-J.), and the Department of Pediatrics, Immunology, and Nephrology, Polish Mother's Memorial Hospital Research Institute, Lodz (M.T.) - all in Poland; the Department of Pediatric Nephrology, University Hospitals Leuven (D.M., S.D.R.), and PKD Research Group, Laboratory of Ion Channel Research, Department of Cellular and Molecular Medicine, KU Leuven (D.M.), Leuven, and the Division of Nephrology, Department of Pediatrics, University Hospital Center of Liège, Liège (J.L.) - all in Belgium; the Department of Pediatric Nephrology, University Hospital Vall d'Hebron, and Universidad Autónoma de Barcelona, Hospital Vall d'Hebron (G.A.), and Pediatric Nephrology, Hospital General de Granollers, Universitat Internacional de Catalunya (M.C.), Barcelona, and Hospital General Universitario Santa Lucía, Cartagena (J.E.C.S.) - all in Spain; the University of Cologne, Faculty of Medicine and University Hospital Cologne, Children's and Adolescents' Hospital, Cologne (L.T.W.), and the Division of Pediatric Nephrology, Center for Pediatrics and Adolescent Medicine, Heidelberg University Hospital, Heidelberg (O.M., F.S.) - both in Germany; and the Division of Pediatric Nephrology, Centro Materno Infantil do Norte, Centro Hospitalar Universitário do Porto, Porto, Portugal (A.C.A.).
• N. Engl. J. Med. 2023 Sep 14; 389 (11): 987997987-997.

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.).Copyright © 2023 Massachusetts Medical Society.

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