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

Study Overview
=================
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.

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

Conditions
-----------------
Bacteriuria

Intervention / Treatment
-----------------
* Dietary Supplement: 2 cranberry capsules
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female residents; long term residents English speaking; and age ≥ 65 years. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants were randomized to cranberry or placebo capsules.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2 cranberry capsules<br>Experimental: 2 cranberry capsules | Dietary Supplement: 2 cranberry capsules<br>* Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)<br>|
| Placebo Comparator: 2 placebo capsules<br>Experimental: 2 placebo capsules qd | Dietary Supplement: Placebo<br>* Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | One year | 
| Number of Hospitalizations |  | One year | 
| Number of Deaths |  | 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. | 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). | 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. | One Year | 
| Subjects With 1, 2, or 3 Episodes of UTIs | 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. | One year |