A Trial of Cranberry Capsules for Urinary Tract Infection Prevention in Nursing Home Residents
- Conditions
- Bacteriuria
- Interventions
- Dietary Supplement: 2 cranberry capsulesDietary Supplement: Placebo
- Registration Number
- NCT01691430
- Lead Sponsor
- Yale University
- 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 Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 185
- female residents;
- long term residents
- English speaking; and
- age ≥ 65 years.
- 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]);
- residents who are on chronic suppressive antibiotic or anti-infective (i.e., mandelamine) therapy for recurrent UTI;
- residents with end stage renal disease on dialysis (they do not regularly produce urine);
- residents unable to produce a baseline clean catch urine specimen for collection;
- residents on warfarin therapy because of a potential interaction of warfarin and cranberry juice;
- residents with a history of nephrolithiasis because cranberry may increase the risk of nephrolithiasis;
- have an indwelling bladder catheter in place;
- have an allergy to cranberry products;
- are being treated with cranberry products;
- residence <4 weeks.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 cranberry capsules 2 cranberry capsules Experimental: 2 cranberry capsules 2 placebo capsules Placebo Experimental: 2 placebo capsules qd
- Primary Outcome Measures
Name Time Method Participants With Urine Cultures With Bacteriuria (>100,000 Cfu/ml or >=100,000 Cfu/ml) Plus Pyuria (Any WBC) One year Clean catch urine cultures and urinalyses will be obtained every two months for each participant for study purposes.
- Secondary Outcome Measures
Name Time Method Number of Deaths One year Number of Antibiotic Prescriptions 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 Antibiotic Prescriptions for Suspected UTI 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.
Number of Episodes of Symptomatic UTI 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.
Subjects With 1, 2, or 3 Episodes of UTIs 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.
Bacteriuria With Multidrug-resistant Gram-negative Bacilli One year All urine culture data will be reviewed to determine presence of multidrug-resistant gram-negative bacilli (resistance to ≥3 of the following antibiotics: ampicillinsulbactam,cefazolin, ceftriaxone, ceftazidime, fluoroquinolones, piperacillin-tazobactam, meropenem, imipenem, and trimethoprim-sulfamethoxazole).
Number of Hospitalizations One year
Trial Locations
- Locations (21)
Ludlowe Health Care Center
🇺🇸Fairfield, Connecticut, United States
Water's Edge Center for Health & Rehabilitation
🇺🇸Middletown, Connecticut, United States
Advanced Nursing & Rehab Center of New Haven
🇺🇸New Haven, Connecticut, United States
Hughes Health & Rehab Center
🇺🇸West Hartford, Connecticut, United States
Branford Hills Health Care
🇺🇸Branford, Connecticut, United States
Northbridge Health Care Center
🇺🇸Bridgeport, Connecticut, United States
Glastonbury Health Care Center
🇺🇸Glastonbury, Connecticut, United States
Bridgeport Health Care Center
🇺🇸Bridgeport, Connecticut, United States
Bridgeport Manor
🇺🇸Bridgeport, Connecticut, United States
Riverside Health & Rehabilitation Center
🇺🇸East Hartford, Connecticut, United States
The Nathaniel Witherell
🇺🇸Greenwich, Connecticut, United States
Avery Heights
🇺🇸Hartford, Connecticut, United States
Arden House Care and Rehabilitation Center
🇺🇸Hamden, Connecticut, United States
Hamden Health Care Center
🇺🇸Hamden, Connecticut, United States
Shady Knoll Health Center
🇺🇸Seymour, Connecticut, United States
Wadsworth Glen Health Care and Rehabilitation Center
🇺🇸Middletown, Connecticut, United States
Mary Wade Home
🇺🇸New Haven, Connecticut, United States
Grimes Center
🇺🇸New Haven, Connecticut, United States
Lord Chamberlain Nursing & Rehabilitation Center
🇺🇸Stratford, Connecticut, United States
Village Green of Wallingford
🇺🇸Wallingford, Connecticut, United States
Abbott Terrace Health Center
🇺🇸Waterbury, Connecticut, United States