Usefulness of Antimicrobial Prophylaxis in Children With Isolated Vesico-Ureteral Reflux.

• Sponsor: Nantes University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00200616
• Collaborator: (none)
• Enrollment: 232
• Location: 1
• Duration (Months): 63
• Patients Per Site Per Month: 3.7

Study Details

Study Description

Brief Summary

Randomized, prospective, multicenter study in order to assess the usefulness of antimicrobial prophylaxis in children with isolated vesico-ureteral reflux (grade III or less).

Condition or Disease	Intervention/Treatment	Phase
Urinary Tract Infection	Procedure: Antimicrobial prophylaxis	N/A

Detailed Description

A voiding cystourethrogram was performed for each child less than 3 years old with a first urinary tract infection. In case of vesico-ureteral reflux, a randomization was done between continuous antimicrobial prophylaxis with low dose of trimethoprim-sulfamethoxazole and no antibioprophylaxis. Duration of follow up was 18 months.

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Antimicrobial Prophylaxis in Children With Isolated Vesico-Ureteral Reflux. A Randomised Prospective Study of Continuous Low Dose of Trimethoprim-Sulfamethoxazole Versus Surveillance.
• Study Start Date: Apr 1, 2001
• Actual Primary Completion Date: Jul 1, 2006
• Actual Study Completion Date: Jul 1, 2006

Outcome Measures

Primary Outcome Measures

1. End point : recurrence of urinary tract infection during the study period (0 è 18 months) []

Secondary Outcome Measures

1. 1) Type of urinary tract infection (pyelonephritis or cystitis) []

2. 2) Evaluation of the quality of life with a validated questionnaire done at 9 months []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Day to 3 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Children less than 3 years old

• First proved urinary tract infectionIsolated vesico-ureteral reflux

• Parents have been fully informed and have given written informed consent to participate in the study

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nantes University Hospital	Nantes		France

Sponsors and Collaborators

• Nantes University Hospital

Investigators

• Principal Investigator: Claude GUYOT, MD, Nantes University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00200616
• Other Study ID Numbers: BRD/00/10-O
• First Posted: Sep 20, 2005
• Last Update Posted: Jul 1, 2008
• Last Verified: Jun 1, 2008

• Keywords provided by , ,: Urinary tract infection; Vesico-renal reflux; Child; Antimicrobial prophylaxis; Recurrence of urinary tract infection
• Additional relevant MeSH terms: Infections; Urinary Tract Infections; Vesico-Ureteral Reflux; Anti-Infective Agents; Anti-Bacterial Agents

Study Results

No Results Posted as of Jul 1, 2008