Antibiotic Prophylaxis to Prevent Post-procedure UTI After VCUG

NCT05438082 | Unknown Phase 4

• 1 other identifier: 19481
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

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 A recent unpublished survey of Society of Fetal Urologists (SFU) completed by this study team found that 87% of respondents reported having patients who develop fUTI following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

Conditions

Antibiotic Prophylaxis; Voiding Cystourethrogram; Febrile Urinary Tract Infection

Outcome Measures

Primary Outcomes (1)

• Feasibility of pilot study: randomization, compliance, enrollment targets

  The primary feasibility outcomes for the pilot study will be recruitment rate (\>50% of eligible infants enrolled), randomization rate (percentage of participants randomized, \>95%), medication compliance rate (\>80%), percentage of the primary endpoints (febrile UTI) and cost of being in the trial per patient. We would also aim to demonstrate a \<15% rate of protocol violations, and loss to follow-up. The major clinical outcome for the pilot study is to determine the event rate of UTI in patient post-procedure to inform the sample size calculation for the larger trial.

  12 months

Secondary Outcomes (2)

• Resource Allocation

  12 months

• Febrile UTI within 7 days of VCUG Procedure

  7 days

Study Arms (2)

Antibiotic Prophylaxis

EXPERIMENTAL

one dose of either Trimethoprim (if \< 2 months) or Trimethoprim-Sulfamethoxazole (if ≥ 2 months) or placebo in suspension. Dosing regimen for the active treatment (Trimethoprim) will be based on weight (5mg/kg of Trimethoprim component) with a maximum dosage of 320mg.

Drug: Antibiotic Prophylaxis

Placebo

PLACEBO COMPARATOR

The placebo group will receive an equal volume of placebo suspension that has been developed to have the same colour and taste as the antibiotic to preserve blinding.

Other: Placebo

Interventions

Antibiotic Prophylaxis DRUG

This trial will contain two arms in which patients will be randomized to receive one dose of either Trimethoprim (if \< 2 months) or Trimethoprim-Sulfamethoxazole (if ≥ 2 months) or placebo in suspension. Dosing regimen for the active treatment (Trimethoprim) will be based on weight (5mg/kg of Trimethoprim component) with a maximum dosage of 320mg

Antibiotic Prophylaxis

Placebo OTHER

The placebo group will receive an equal volume of placebo suspension that has been developed to have the same colour and taste as the antibiotic to preserve blinding.

Placebo

Eligibility Criteria

• Age: Up to 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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
• Parent or legal guardian able to provide informed consent

You may not qualify if:

• Chronic antibiotic use
• Allergy to Trimethoprim or Trimethoprim-Sulfamethoxazole

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead

MeSH Terms

Interventions

Antibiotic Prophylaxis

Intervention Hierarchy (Ancestors)

Chemoprevention; Drug Therapy; Therapeutics; Premedication

Central Study Contacts

Sarah Khan, MD

CONTACT

9055212100; khan259@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This trial is a single center, parallel, blinded, randomized, placebo-controlled pilot trial in children

Study Record Dates

• First Submitted: June 24, 2022
• First Posted: June 29, 2022
• Study Start: October 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share