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

Yale University185 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

185

Conditions

Bacteriuria

Interventions

2 cranberry capsulesDIETARY_SUPPLEMENT

Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)

PlaceboDIETARY_SUPPLEMENT

Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)

Eligibility

Sex: FEMALEMin age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (21)

Branford Hills Health Care

Branford, Connecticut, United States

Outcomes

Primary Outcomes

Participants With Urine Cultures With Bacteriuria (>100,000 Cfu/ml or >=100,000 Cfu/ml) Plus Pyuria (Any WBC)

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

Time frame: One year

Secondary Outcomes

Number of Episodes of Symptomatic UTI

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.

Time frame: One year

Number of Hospitalizations

Time frame: One year

Number of Deaths

Time frame: One year

Number of Antibiotic Prescriptions

Chart review will be performed to determine the names and duration of antibiotic prescriptions prescribed by the primary provider on each participant.

Time frame: One year

Bacteriuria With Multidrug-resistant Gram-negative Bacilli

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).

Time frame: One year

Number of Antibiotic Prescriptions for Suspected UTI

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.

Data from ClinicalTrials.gov

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