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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 November 2012 |
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Main ID: |
NCT01114347 |
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Date of registration:
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30/04/2010 |
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Primary sponsor: |
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Public title:
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Prevention of Nosocomial E. Coli Infections After Placement of an Indwelling Catheter During Pelvic Surgery: an Evaluation of Cranberry Gel Capsules
NosoPink |
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Scientific title:
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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 |
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Date of first enrolment:
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June 2010 |
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Target sample size:
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180 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01114347 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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Countries of recruitment
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France
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Contacts
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Name:
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Vincent Letouzey, MD |
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Address:
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Telephone:
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33.4.66.68.32.16 |
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Email:
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vincent.letouzey@chu-nimes.fr |
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Affiliation:
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Name:
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Vincent Letouzey, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre Hospitalier Universitaire de Nîmes |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Bacteriuria
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Cross Infection
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Intervention(s)
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Dietary Supplement: cranberry type A pro anthocyandines
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Dietary Supplement: Placebo
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Primary Outcome(s)
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Presence/absence of Asymptomatic bacteriuria
[Time Frame: 15 days post-op]
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Secondary ID(s)
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2008-AO1604-51
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AOI/2009/VL-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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