Clinical trial NCT05438082: Antibiotic Prophylaxis to Prevent Post-procedure UTI After VCUG
Official title: Antibiotic Prophylaxis to Prevent Post-procedure Urinary Tract Infection After Voiding Cystourethrogram
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Antibiotic Prophylaxis
Voiding Cystourethrogram
Febrile Urinary Tract Infection
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2022-06-29
Enrollment: 84
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This trial is a single center, parallel, blinded, randomized, placebo-controlled pilot trial in children
Primary purpose: PREVENTION

Brief 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 A recent unpublished survey of Society of Fetal Urologists (SFU) completed by this study team found that 87% of respondents reported having patients who develop fUTI following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.

Detailed description: What are the Study Objectives? The primary objective of this pilot trial is to determine the feasibility of conducting a definitive trial investigating whether pre-VCUG antibiotic prophylaxis, when compared to placebo, decreases the risk of fUTI in infants undergoing VCUG for genitourinary abnormalities. The pilot trial will address specific feasibility outcomes including process, resources, management and scientific domains. The pilot will lay the groundwork for the eventual full trial. Funding for the full trial will be sought after preliminary data is collected from the pilot study.

The primary objective for the definitive trial is to determine whether single-dose, preprocedural antibiotic prophylaxis compared to placebo lowers the risk of fUTI in children \< 3 years of age who are undergoing VCUG for the following indications: high-grade (SFU Classification III, IV/UTD 2,3) HN, ureteral dilatation, or bladder abnormalities found during renal ultrasound. The secondary outcomes of the definitive trial will include assessment of adverse event outcomes related to antibiotic prophylaxis administration, including antibiotic resistant UTI pathogens, episodes of antibiotic associated diarrhea, and C. difficile.

Eligibility criteria: Inclusion Criteria:

1. Children \<3 years of age undergoing VCUG for the following indications: high-grade SFU/UTD hydronephrosis, ureteral dilatation, or bladder abnormalities found during renal ultrasound
2. Parent or legal guardian able to provide informed consent

Exclusion Criteria:

1. Chronic antibiotic use
2. Allergy to Trimethoprim or Trimethoprim-Sulfamethoxazole

Primary outcomes:
measure: Feasibility of pilot study: randomization, compliance, enrollment targets
timeFrame: 12 months
Secondary outcomes:
measure: Resource Allocation
timeFrame: 12 months
measure: Febrile UTI within 7 days of VCUG Procedure
timeFrame: 7 days
Other outcomes:
Locations:
Study officials:
References: