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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01691430
First received: August 9, 2012
Last updated: April 7, 2016
Last verified: April 2016

August 9, 2012
April 7, 2016
August 2012
October 2015   (final data collection date for primary outcome measure)
Number of urine cultures with bacteriuria (>100,000 cfu/ml or >=100,000 cfu/ml) plus pyuria (any 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.
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.
Complete list of historical versions of study NCT01691430 on ClinicalTrials.gov Archive Site
  • Number of episodes of symptomatic UTI [ Time Frame: One year ] [ Designated as safety issue: No ]
    Suspected UTI episodes that are recorded in the medical record by the primary provider will be reviewed by chart review, symptoms will be recorded, and two adjudicators will determine if the definition of symptomatic UTI is met.
  • 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.
  • Number of antibiotic prescriptions for suspected UTI [ 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's suspected UTI.
  • 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.
  • 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 reduction of bacteriuria plus pyuria in female nursing home residents. 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 3
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 cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)
  • Dietary Supplement: Placebo
    Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)
  • Active Comparator: 2 cranberry capsules
    Experimental: 2 cranberry capsules
    Intervention: Dietary Supplement: 2 cranberry capsules
  • Placebo Comparator: 2 placebo capsules
    Experimental: 2 placebo capsules qd
    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.
 
Completed
185
October 2015
October 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. female residents;
  2. long term residents
  3. English speaking; and
  4. age ≥ 65 years.

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   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01691430
1112009472
No
Not Provided
Not Provided
Yale University
Yale University
Not Provided
Principal Investigator: Manisha Juthani-Mehta, M.D. Yale School of Medicine
Yale University
April 2016

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