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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Controlled Trial of Cranberry Capsules for UTI Prevention in Nursing Home Residents

Brief Summary: 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.

Detailed Summary:
Sponsor: Yale University

Current Primary Outcome: Number of urine cultures with bacteriuria (>100,000 cfu/ml or >=100,000 cfu/ml) plus pyuria (any WBC) [ Time Frame: One year ]

Clean catch urine cultures and urinalyses will be obtained every two months for each participant for study purposes.


Original Primary Outcome: Number of urine cultures with bacteriuria (>100,000 cfu/ml) plus pyuria (>10 WBC) [ Time Frame: One year ]

Clean catch urine cultures and urinalyses will be obtained every two months for each participant for study purposes.


Current Secondary Outcome:

  • Number of episodes of symptomatic UTI [ Time Frame: One year ]
    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 ]
  • Number of deaths [ Time Frame: One year ]
  • Number of antibiotic prescriptions [ Time Frame: One year ]
    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 ]
    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 ]
    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.


Original Secondary Outcome:

  • Number of episodes of UTI [ Time Frame: One year ]
    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 ]
  • Number of deaths [ Time Frame: One year ]
  • Number of antibiotic prescriptions [ Time Frame: One year ]
    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 ]
    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.


Information By: Yale University

Dates:
Date Received: August 9, 2012
Date Started: August 2012
Date Completion:
Last Updated: April 7, 2016
Last Verified: April 2016