PREDICT
Trial question
What is the role of antibiotic prophylaxis in infants with grade III-V vesicoureteral reflux and no previous UTIs?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
22.0% female
78.0% male
N = 292
292 patients (65 female, 227 male).
Inclusion criteria: infants, 1-5 months of age, with grade III-V vesicoureteral reflux and no previous UTIs.
Key exclusion criteria: previous UTI; posterior urethral valves; neurogenic bladder; ureteropelvic junction or ureterovesical junction obstruction.
Interventions
N=146 antibiotic prophylaxis (continuous antibiotic prophylaxis for 24 months).
N=146 no treatment (no antibiotic prophylaxis).
Primary outcome
First urinary tract infection
21.2%
35.6%
35.6 %
26.7 %
17.8 %
8.9 %
0.0 %
Antibiotic
prophylaxis
No
treatment
Significant
decrease ▼
NNT = 6
Significant decrease in first UTI (21.2% vs. 35.6%; HR 0.55, 95% CI 0.35 to 0.86).
Secondary outcomes
Significant decrease in total symptomatic UTI (41.1% vs. 54.1%; RR 0.76, 95% CI 0.59 to 0.97).
No significant difference in new kidney scars at 24 months (14.3% vs. 11.6%; RR 1.22, 95% CI 0.69 to 2.18).
No significant difference in eGFR at 24 months (112.3 mL/min/1.73 m² vs. 109.5 mL/min/1.73 m²; MD 2.8, 95% CI -4.8 to 10.3).
Safety outcomes
No significant difference in serious adverse events.
Conclusion
In infants, 1-5 months of age, with grade III-V vesicoureteral reflux and no previous UTIs, antibiotic prophylaxis was superior to no treatment with respect to first UTI.
Reference
William Morello, Esra Baskin, Augustina Jankauskiene et al. Antibiotic Prophylaxis in Infants with Grade III, IV, or V Vesicoureteral Reflux. N Engl J Med. 2023 Sep 14;389(11):987-997.
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