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

This study is currently recruiting participants.

Verified March 2013 by Centre Hospitalier Universitaire de Nīmes

Sponsor:

Information provided by (Responsible Party):

Centre Hospitalier Universitaire de Nīmes

ClinicalTrials.gov Identifier:

NCT01114347

First received: April 30, 2010

Last updated: March 29, 2013

Last verified: March 2013

History of Changes

Purpose

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	Intervention	Phase
Cross Infection Bacteriuria	Dietary Supplement: cranberry type A pro anthocyandines Dietary Supplement: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: E. Coli Infections

Drug Information available for: Escherichia coli

U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:

Presence/absence of Asymptomatic bacteriuria [ Time Frame: 15 days post-op ] [ Designated as safety issue: No ]
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)

Estimated Enrollment:	180
Study Start Date:	June 2010
Estimated Study Completion Date:	August 2013
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01114347

Contacts

Contact: Vincent Letouzey, MD	33.4.66.68.32.16	vincent.letouzey@chu-nimes.fr
Contact: Carey M Suehs, PhD	33.4.66.68.67.88	carey.suehs@chu-nimes.fr

Locations

France
CHU de Nîmes - Hôpital Universitaire Carémeau	Recruiting
Nîmes, France, 30029
Principal Investigator: Vincent Letouzey, MD
Sub-Investigator: Renaud de Tayrac, MD PhD
Sub-Investigator: Pierre Marès, MD PhD
Sub-Investigator: Albery Sotto, MD PhD
Sub-Investigator: Philippe Lavigne, MD
Sub-Investigator: Laurent Boileau, MD

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nīmes

Investigators

Principal Investigator:

Vincent Letouzey, MD

Centre Hospitalier Universitaire de Nîmes

More Information

No publications provided

Responsible Party:	Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:	NCT01114347 History of Changes
Other Study ID Numbers:	AOI/2009/VL-01, 2008-AO1604-51
Study First Received:	April 30, 2010
Last Updated:	March 29, 2013
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) France: Committee for the Protection of Personnes

Additional relevant MeSH terms:

Bacteriuria
Cross Infection
Escherichia coli Infections
Urinary Tract Infections
Infection

Urologic Diseases
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on May 22, 2013

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