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

Bacteriuria Clinical Trial

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Official title:

Prevention of Nosocomial Escherichia Coli Infections After Placement of an Indwelling Catheter During Pelvic Surgery: a Randomized, Prospective, Double Blind Study for the Evaluation of Cranberry (Vaccinium Macrocarpon) Gel Capsules

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01114347
• Other study ID #: AOI/2009/VL-01
• Secondary ID: 2008-AO1604-51
• Status: Completed
• Phase: Phase 2
• First received: April 30, 2010
• Last updated: March 25, 2015
• Start date: August 2010
• Est. completion date: March 2014

Study information

• Verified date: March 2015
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: March 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bacteriuria
• Cross Infection
• Infection

Intervention

Dietary Supplement:
• cranberry type A pro anthocyandines
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
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.

Locations

Country	Name	City	State
France	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence/absence of Asymptomatic bacteriuria	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)	15 days post-op	No