Antibiotic Prophylaxis to Prevent Post-procedure UTI After VCUG

NCT ID: NCT05438082

Last Updated: 2023-04-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-31
• Study Completion Date: 2024-12-31

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 A recent unpublished survey of Society of Fetal Urologists (SFU) completed by this study team found that 87% of respondents reported having patients who develop fUTI following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

Conditions

Antibiotic Prophylaxis; Voiding Cystourethrogram; Febrile Urinary Tract Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Antibiotic Prophylaxis

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.

Group Type: EXPERIMENTAL

Antibiotic Prophylaxis

Intervention Type: 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

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

Antibiotic Prophylaxis

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

Intervention Type: DRUG

Placebo

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.

Intervention Type: OTHER

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

• Maximum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hamilton Health Sciences Corporation

OTHER

Sponsor Role: lead

Responsible Party

Sarah Khan

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Sarah Khan, MD

Role: CONTACT

khan259@mcmaster.ca

9055212100 ext. 77577

Other Identifiers

19481

Identifier Type: -

Identifier Source: org_study_id