Prevention of Nosocomial E. Coli Infections After Placement of an Indwelling Catheter During Pelvic Surgery: an Evaluation of Cranberry Gel Capsules

Phase 2

Completed

• Conditions: Cross Infection; Bacteriuria
• Interventions: Dietary Supplement: cranberry type A pro anthocyandines; Dietary Supplement: Placebo

• Registration Number: NCT01114347
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

Indwelling urinary catheters are a primary site for nosocomial infections. The purpose of this study is to evaluate the anti-adhesive properties of Cranberry type A pro anthocyanidine gel capsules in the prevention Escherichia coli infections on indwelling urinary catheters placed in patients following pelvic surgery. The investigators primary working hypothesis is that cranberry treatment decreases E. coli colonization on indwelling urinary catheters, thus preventing nosocomial urinary infections following pelvic surgery.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-30
• Study First Submitted QC: 2010-04-30
• Study First Posted: 2010-05-03
• Study Start: 2010-08
• Primary Completion: 2014-02
• Study Completion: 2014-03
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-25
• Last Update Posted: 2015-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

• Patient is cared for by the department of the Gynecology at the Nîmes Unversity Hospital
• The patient is programmed for surgery with placement an indwelling catheter for 48 hours with a sterile urinary cytobacteriologic exam at inclusion

Exclusion Criteria

• the urinary cytobacteriologic exam at inclusion is positive
• the patient is taking antivitamin K
• the patient is taking antibiotics
• history of urolithiasis
• the patient refuses to participate
• the patient is pregnant or nursing
• the patient is not associated with a social security system (no insurance)
• the patient is under guardianship

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cranberry	cranberry type A pro anthocyandines	Patients randomized to this arm will recieve one gel capsule containing cranberry PAC (36 mg of type A pro anthocyandines: Urell, Pharmatoka) per day starting at the day of the pelvic surgery (j0) until day 10 postop (j10). The gel capsule in taken orally in the morning with a large glass of water.
Placebo	Placebo	The patients randomized to this arm will recieve one placebo gel capsule per day starting on the day of the pelvic surgery (j0) until the 10th day post-op (j10). The gel capsule is taken orally in the morning with a large glass of water. The placebo contains lactose and is conditioned in a manner to be identical in caliber and color with the experimental treatment gel capsules.

Primary Outcome Measures

Name	Time	Method
Presence/absence of Asymptomatic bacteriuria	15 days post-op	Presence/absence of greater than 10\^5 unit forming E. coli colonies per ml of urine with absence of functional urinary infection symptoms (mictional burning, pollakiuria, dysuria, urgency, suprapubic heaviness)

Trial Locations

Locations (1)

CHU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes, France