A Trial of Cranberry Capsules for Urinary Tract Infection Prevention in Nursing Home Residents

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Yale University
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01691430
First received: August 9, 2012
Last updated: April 3, 2014
Last verified: January 2014

August 9, 2012
April 3, 2014
August 2012
January 2016   (final data collection date for primary outcome measure)
Number of urine cultures with bacteriuria (>100,000 cfu/ml) plus pyuria (>10 WBC) [ Time Frame: One year ] [ Designated as safety issue: No ]
Clean catch urine cultures and urinalyses will be obtained every two months for each participant for study purposes.
Same as current
Complete list of historical versions of study NCT01691430 on ClinicalTrials.gov Archive Site
  • Number of episodes of UTI [ Time Frame: One year ] [ Designated as safety issue: No ]
    UTI episodes that are recorded in the medical record by the primary provider will be collected by chart review.
  • Number of hospitalizations [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • Number of deaths [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • Number of antibiotic prescriptions [ Time Frame: One year ] [ Designated as safety issue: No ]
    Chart review will be performed to determine the names and duration of antibiotic prescriptions prescribed by the primary provider on each participant.
  • Number of multi-drug resistant organisms in each participant [ Time Frame: One year ] [ Designated as safety issue: No ]
    Chart review will be performed to determine if multi-drug resistant organisms were isolated from clinical samples (e.g., sputum, urine, blood cultures) submitted by the primary provider.
Same as current
  • Number of adverse events in participants [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • Adherence to capsule intake by all participants [ Time Frame: One year ] [ Designated as safety issue: No ]
Same as current
 
A Trial of Cranberry Capsules for Urinary Tract Infection Prevention in Nursing Home Residents
A Randomized, Controlled Trial of Cranberry Capsules for UTI Prevention in Nursing Home Residents

Urinary tract infection (UTI) is the most common infection in nursing home residents, and bacteriuria is the greatest trigger for antimicrobial therapy in the nursing home setting. The primary aim of this study is to test the efficacy of two oral cranberry capsules per day in the prevention of bacteriuria in female nursing home residents. The secondary aim is to compare the occurrence of urinary tract specific symptoms in the cranberry capsule versus placebo groups. These aims will be accomplished by conducting a double blind randomized placebo controlled efficacy trial of two oral cranberry capsules daily versus placebo in a cohort of Connecticut female nursing home residents.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Bacteriuria
  • Dietary Supplement: 2 cranberry capsules
    Two 36mg cranberry capsules all qhs
    Other Name: Ellura
  • Dietary Supplement: Placebo
    Two 36mg placebo capsules all qhs
    Other Name: Placebo
  • Active Comparator: 2 cranberry capsules
    Experimental: 2 cranberry capsules
    Intervention: Dietary Supplement: 2 cranberry capsules
  • Placebo Comparator: 2 placebo capsules
    Experimental: 2 placebo capsules all qhs
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
180
January 2016
January 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. female residents;
  2. age ≥ 65 years;
  3. long term residents

Exclusion Criteria:

  1. residents that are not expected to be in the nursing home for at least one month (i.e., short term rehabilitation, pending discharge, terminal [life expectancy < 1 month]);
  2. residents who are on chronic suppressive antibiotic or anti-infective (i.e., mandelamine) therapy for recurrent UTI;
  3. residents with end stage renal disease on dialysis (they do not regularly produce urine);
  4. residents unable to produce a baseline clean catch urine specimen for collection;
  5. residents on warfarin therapy because of a potential interaction of warfarin and cranberry juice;
  6. residents with a history of nephrolithiasis because cranberry may increase the risk of nephrolithiasis;
  7. have an indwelling bladder catheter in place;
  8. have an allergy to cranberry products;
  9. are being treated with cranberry products;
  10. residence <4 weeks.
Female
65 Years and older
Yes
Contact: Manisha Juthani-Mehta, M.D. 203-737-2109 manisha.juthanimehta@yale.edu
United States
 
NCT01691430
1112009472
No
Yale University
Yale University
Not Provided
Principal Investigator: Manisha Juthani-Mehta, M.D. Yale School of Medicine
Yale University
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP