Antibiotic Prophylaxis in Infants with Grade III, IV, or V Vesicoureteral Reflux.
Journal
The New England journal of medicine
ISSN: 1533-4406
Titre abrégé: N Engl J Med
Pays: United States
ID NLM: 0255562
Informations de publication
Date de publication:
14 Sep 2023
14 Sep 2023
Historique:
medline:
15
9
2023
pubmed:
13
9
2023
entrez:
13
9
2023
Statut:
ppublish
Résumé
The efficacy of continuous antibiotic prophylaxis in preventing urinary tract infection (UTI) in infants with grade III, IV, or V vesicoureteral reflux is controversial. 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. 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- 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-
Sections du résumé
BACKGROUND
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
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
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-
CONCLUSIONS
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-
Identifiants
pubmed: 37702442
doi: 10.1056/NEJMoa2300161
doi:
Substances chimiques
Anti-Bacterial Agents
0
Banques de données
ClinicalTrials.gov
['NCT02021006']
EudraCT
['2013-000309-21']
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
987-997Subventions
Organisme : Ministero della Salute
ID : RF-2010-2308451
Investigateurs
Giovanni Montini
(G)
William Morello
(W)
Claudio La Scola
(C)
Giorgio Piaggio
(G)
Marco Pennesi
(M)
Alberto Edefonti
(A)
Dario Minoli
(D)
Angela La Manna
(A)
Ilaria Luongo
(I)
Rosa Cusumano
(R)
Maria Luisa Capitanucci
(ML)
Germana Longo
(G)
Irene Alberici
(I)
Marco Materassi
(M)
Francesca Becherucci
(F)
Roberto Chimenz
(R)
Milena Brugnara
(M)
Walburga Cassar
(W)
Aleksandra Zurowska
(A)
Piotr Czarniak
(P)
Przemysław Szcześniak
(P)
Anna Kranz
(A)
Dorota Drozdz
(D)
Anna Wasilewska
(A)
Katarzyna Taranta-Janusz
(K)
Marcin Tkaczyk
(M)
Lidia Hyla-Klekot
(L)
Tomasz Koszutski
(T)
Maria Roszkowska Blaim
(M)
Grażyna Krzemień
(G)
Agnieszka Szmigielska
(A)
Danuta Zwolinska
(D)
Maria Szczepanska
(M)
Augustina Jankauskiene
(A)
Dovile Ruzgiene
(D)
Sarunas Rudaitis
(S)
Esra Baskin
(E)
Kaan Gülleroglu
(K)
Fatos Yalcinkaya
(F)
Sinan Genc
(S)
Birsin Ozcakar
(B)
Nurcan Cengiz
(N)
Ali Anarat
(A)
Aysun Bayazit
(A)
Engin Melek
(E)
Bahriye Atmis
(B)
Sevgi Mir
(S)
Oguz Soylemezoglu
(O)
Ali Duzova
(A)
Salim Caliskan
(S)
Lale Sever
(L)
Nur Canpolat
(N)
Sevinc Emre
(S)
Alev Yılmaz
(A)
Zela Ekinci
(Z)
Harika Alpay
(H)
Nurdan Yıldız
(N)
Nilgun Cakar
(N)
Gurkan Genç
(G)
Selcuk Yuksel
(S)
Ariane Zaloszyc
(A)
Alberto Caldas Afonso
(A)
Ana Teixeira
(A)
Lutz Thorsten Weber
(LT)
Otto Mehls
(O)
Franz Schaefer
(F)
Gema Ariceta
(G)
Margarita Català
(M)
Jose Eugenio Cabrera Sevilla
(JE)
Djalila Mekahli
(D)
Jacques Lombet
(J)
Per Brandström
(P)
Friederike Körber
(F)
Suat Fitoz
(S)
Diego De Palma
(D)
Pietro Zucchetta
(P)
Donatas Vajauskas
(D)
Informations de copyright
Copyright © 2023 Massachusetts Medical Society.