Ignite Creation Date:
2024-05-06 @ 5:47 PM
Last Modification Date:
2024-10-26 @ 2:36 PM
Study NCT ID:
NCT05438082
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-04-12
First Post:
2022-06-24
Brief Title:
Antibiotic Prophylaxis to Prevent Post-procedure UTI After VCUG
Sponsor:
Hamilton Health Sciences Corporation
Organization:
McMaster University
Study Overview
Official Title:
Antibiotic Prophylaxis to Prevent Post-procedure Urinary Tract Infection After Voiding Cystourethrogram
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
APPrUV
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The current practice of pre-VCUG antibiotic prophylaxis is highly variable A recent unpublished survey of Society of Fetal Urologists SFU completed by this study team found that 87 of respondents reported having patients who develop fUTI following VCUG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 IVUTD 23 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
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 IVUTD 23 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None