drugset / Trial / NCT05438082

Antibiotic Prophylaxis to Prevent Post-procedure UTI After VCUG

NCT05438082

Phase 4 Unknown 84 enrolled Hamilton Health Sciences Corporation
RandomizedParallel-groupQuadruple-blindPrevention

Summary

The current practice of pre-VCUG antibiotic prophylaxis is highly variable. A recent unpublished survey of Society of Fetal Urologists (SFU) completed by this study team found that 87% of respondents reported having patients who develop fUTI following VCUG, with 30% of respondents prophylaxing for fUTI in patients undergoing VCUG. The current lack of best practice guidelines regarding antibiotic prophylaxis prior to VCUG due to low quality of current literature, and a growing concern around risks of unnecessary antibiotic exposure suggests the need for an RCT. The results of this pilot trial will inform the ability to conduct a definitive RCT on this important subject. The results of the definitive trial would have important clinical and economic implications.

Timeline

Start
2023-10
Primary completion
2024-10
Completion
2024-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Trimethoprim Small molecule 5 mg/kg
Subject trimethoprim-sulfamethoxazole Unknown 5 mg/kg