Phase 3
N=185
A Trial of Cranberry Capsules for Urinary Tract Infection Prevention in Nursing Home Residents
Bacteriuria
Bottom Line
View on ClinicalTrials.gov: NCT01691430 ↗Enrolled (actual)
185
Serious AEs
62.7%
Results posted
Jan 2018
Primary outcome: Primary: Participants With Urine Cultures With Bacteriuria (>100,000 Cfu/ml or >=100,000 Cfu/ml) Plus Pyuria (Any WBC) — 26; 32; 21; 27 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 2 cranberry capsules (Dietary_supplement); Placebo (Dietary_supplement)
- Age
- Older Adult · 65+ yrs
- Sex
- Female
- Sponsor
- Yale University
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants With Urine Cultures With Bacteriuria (>100,000 Cfu/ml or >=100,000 Cfu/ml) Plus Pyuria (Any WBC) |
26; 32; 21; 27; 15; 26 | — |
| SECONDARY Number of Episodes of Symptomatic UTI |
10; 12 | — |
| SECONDARY Number of Hospitalizations |
33; 50 | — |
| SECONDARY Number of Deaths |
17; 16 | — |
| SECONDARY Number of Antibiotic Prescriptions |
1415; 1883 | — |
| SECONDARY Bacteriuria With Multidrug-resistant Gram-negative Bacilli |
9; 24 | — |
| SECONDARY Number of Antibiotic Prescriptions for Suspected UTI |
692; 909 | — |
| SECONDARY Subjects With 1, 2, or 3 Episodes of UTIs |
8; 7; 1; 1; 0; 1 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01691430). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.