Antibiotic Prophylaxis in Infants with Grade III, IV, or V Vesicoureteral Reflux.

Morello W., Baskin E., Jankauskiene A., Yalcinkaya F., Zurowska A., Puccio G., ...Daha Fazla

New England Journal of Medicine, cilt.389, sa.11, ss.987-997, 2023 (SCI-Expanded) identifier identifier

  • Yayın Türü: Makale / Tam Makale
  • Cilt numarası: 389 Sayı: 11
  • Basım Tarihi: 2023
  • Doi Numarası: 10.1056/nejmoa2300161
  • Dergi Adı: New England Journal of Medicine
  • Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus, Academic Search Premier, PASCAL, Abstracts in Social Gerontology, AgeLine, BIOSIS, CAB Abstracts, Chemical Abstracts Core, CINAHL, Educational research abstracts (ERA), Food Science & Technology Abstracts, Gender Studies Database, International Pharmaceutical Abstracts, MLA - Modern Language Association Database, Public Affairs Index, Veterinary Science Database
  • Sayfa Sayıları: ss.987-997
  • Anahtar Kelimeler: Bacterial Infections, Clinical Medicine, Clinical Medicine General, Congenital Kidney Disease, Infectious Disease, Nephrology, Pediatrics, Pediatrics General, UTI/Pyelonephritis
  • Çanakkale Onsekiz Mart Üniversitesi Adresli: Hayır

Özet

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.)