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

Sponsor

Centre Hospitalier Universitaire de Nīmes (Other)

Overall Status

Completed

CT.gov ID

NCT01114347

Collaborator

(none)

270

Enrollment

Location

Arms

Duration (Months)

6.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cross Infection Bacteriuria	Dietary Supplement: cranberry type A pro anthocyandines Dietary Supplement: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

270 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

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

Study Start Date :

Aug 1, 2010

Actual Primary Completion Date :

Feb 1, 2014

Actual Study Completion Date :

Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cranberry 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.	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 Comparator: 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.	Dietary Supplement: 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.

Arm

Intervention/Treatment

Experimental: Cranberry

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.

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 Comparator: 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.

Dietary Supplement: 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.

Outcome Measures

Primary Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes		France	30029

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nīmes

Investigators

Principal Investigator: Vincent Letouzey, MD, Centre Hospitalier Universitaire de Nîmes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Nīmes

ClinicalTrials.gov Identifier:

NCT01114347

Other Study ID Numbers:

AOI/2009/VL-01
2008-AO1604-51

First Posted:

May 3, 2010

Last Update Posted:

Mar 26, 2015

Last Verified:

Mar 1, 2015

Additional relevant MeSH terms:

Infections

Communicable Diseases

Bacteriuria

Cross Infection

Study Results

No Results Posted as of Mar 26, 2015