search
Back to results

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

Primary Purpose

Bacteriuria

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
2 cranberry capsules
Placebo
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bacteriuria

Eligibility Criteria

65 Years - undefined (Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Branford Hills Health Care
  • Northbridge Health Care Center
  • Bridgeport Health Care Center
  • Bridgeport Manor
  • Riverside Health & Rehabilitation Center
  • Ludlowe Health Care Center
  • Glastonbury Health Care Center
  • The Nathaniel Witherell
  • Arden House Care and Rehabilitation Center
  • Hamden Health Care Center
  • Avery Heights
  • Wadsworth Glen Health Care and Rehabilitation Center
  • Water's Edge Center for Health & Rehabilitation
  • Grimes Center
  • Mary Wade Home
  • Advanced Nursing & Rehab Center of New Haven
  • Shady Knoll Health Center
  • Lord Chamberlain Nursing & Rehabilitation Center
  • Village Green of Wallingford
  • Abbott Terrace Health Center
  • Hughes Health & Rehab Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

2 cranberry capsules

2 placebo capsules

Arm Description

Experimental: 2 cranberry capsules

Experimental: 2 placebo capsules qd

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Number of Hospitalizations
Number of Deaths
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.
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).
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.
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.

Full Information

First Posted
August 9, 2012
Last Updated
March 4, 2020
Sponsor
Yale University
Collaborators
National Institute on Aging (NIA)
search

1. Study Identification

Unique Protocol Identification Number
NCT01691430
Brief Title
A Trial of Cranberry Capsules for Urinary Tract Infection Prevention in Nursing Home Residents
Official Title
A Randomized, Controlled Trial of Cranberry Capsules for UTI Prevention in Nursing Home Residents
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacteriuria

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Participants were randomized to cranberry or placebo capsules.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
185 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2 cranberry capsules
Arm Type
Active Comparator
Arm Description
Experimental: 2 cranberry capsules
Arm Title
2 placebo capsules
Arm Type
Placebo Comparator
Arm Description
Experimental: 2 placebo capsules qd
Intervention Type
Dietary Supplement
Intervention Name(s)
2 cranberry capsules
Intervention Description
Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)
Primary Outcome Measure Information:
Title
Participants With Urine Cultures With Bacteriuria (>100,000 Cfu/ml or >=100,000 Cfu/ml) Plus Pyuria (Any WBC)
Description
Clean catch urine cultures and urinalyses will be obtained every two months for each participant for study purposes.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Number of Episodes of Symptomatic UTI
Description
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
Title
Number of Hospitalizations
Time Frame
One year
Title
Number of Deaths
Time Frame
One year
Title
Number of Antibiotic Prescriptions
Description
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
Title
Bacteriuria With Multidrug-resistant Gram-negative Bacilli
Description
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
Title
Number of Antibiotic Prescriptions for Suspected UTI
Description
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.
Time Frame
One Year
Title
Subjects With 1, 2, or 3 Episodes of UTIs
Description
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
Other Pre-specified Outcome Measures:
Title
Number of Adverse Events in Participants
Time Frame
One year
Title
Adherence to Capsule Intake by All Participants
Description
measured by capsules removed from blister packs
Time Frame
One year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manisha Juthani-Mehta, M.D.
Organizational Affiliation
Yale School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Branford Hills Health Care
City
Branford
State/Province
Connecticut
ZIP/Postal Code
06405
Country
United States
Facility Name
Northbridge Health Care Center
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606
Country
United States
Facility Name
Bridgeport Health Care Center
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06610
Country
United States
Facility Name
Bridgeport Manor
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06610
Country
United States
Facility Name
Riverside Health & Rehabilitation Center
City
East Hartford
State/Province
Connecticut
ZIP/Postal Code
06108
Country
United States
Facility Name
Ludlowe Health Care Center
City
Fairfield
State/Province
Connecticut
ZIP/Postal Code
06825
Country
United States
Facility Name
Glastonbury Health Care Center
City
Glastonbury
State/Province
Connecticut
ZIP/Postal Code
06033
Country
United States
Facility Name
The Nathaniel Witherell
City
Greenwich
State/Province
Connecticut
ZIP/Postal Code
06830
Country
United States
Facility Name
Arden House Care and Rehabilitation Center
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06514
Country
United States
Facility Name
Hamden Health Care Center
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06514
Country
United States
Facility Name
Avery Heights
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Wadsworth Glen Health Care and Rehabilitation Center
City
Middletown
State/Province
Connecticut
ZIP/Postal Code
06457
Country
United States
Facility Name
Water's Edge Center for Health & Rehabilitation
City
Middletown
State/Province
Connecticut
ZIP/Postal Code
06457
Country
United States
Facility Name
Grimes Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Mary Wade Home
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Advanced Nursing & Rehab Center of New Haven
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Shady Knoll Health Center
City
Seymour
State/Province
Connecticut
ZIP/Postal Code
06483
Country
United States
Facility Name
Lord Chamberlain Nursing & Rehabilitation Center
City
Stratford
State/Province
Connecticut
ZIP/Postal Code
06614
Country
United States
Facility Name
Village Green of Wallingford
City
Wallingford
State/Province
Connecticut
ZIP/Postal Code
06492
Country
United States
Facility Name
Abbott Terrace Health Center
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06702
Country
United States
Facility Name
Hughes Health & Rehab Center
City
West Hartford
State/Province
Connecticut
ZIP/Postal Code
06119
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29696228
Citation
Datta R, Trentalange M, Van Ness PH, McGloin JM, Guralnik JM, Miller ME, Walkup MP, Nadkarni N, Pahor M, Gill TM, Quagliarello V, Juthani-Mehta M; LIFE Study Group. Serious adverse events of older adults in nursing home and community intervention trials. Contemp Clin Trials Commun. 2017 Dec 21;9:77-80. doi: 10.1016/j.conctc.2017.12.004. eCollection 2018 Mar.
Results Reference
derived
PubMed Identifier
27787564
Citation
Juthani-Mehta M, Van Ness PH, Bianco L, Rink A, Rubeck S, Ginter S, Argraves S, Charpentier P, Acampora D, Trentalange M, Quagliarello V, Peduzzi P. Effect of Cranberry Capsules on Bacteriuria Plus Pyuria Among Older Women in Nursing Homes: A Randomized Clinical Trial. JAMA. 2016 Nov 8;316(18):1879-1887. doi: 10.1001/jama.2016.16141.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs