BacteriuriaPhase 3NCT01691430
A Trial of Cranberry Capsules for Urinary Tract Infection Prevention in Nursing Home Residents
A Phase 3 study testing 2 cranberry capsules in people with Bacteriuria, run by Yale University at 21 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bacteriuria
- What is being tested?
- 2 cranberry capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 185 participants
- Where
- 21 sitesUnited States
- Study dates
- Aug 2012to Oct 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- female residents;
- long term residents
- English speaking; and
- age ≥ 65 years.
Who cannot join
- 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;
Show all 10Show fewer
- have an indwelling bladder catheter in place;
- have an allergy to cranberry products;
- are being treated with cranberry products;
- residence <4 weeks.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Branford Hills Health Care
Branford, Connecticut, 06405
Northbridge Health Care Center
Bridgeport, Connecticut, 06606
Bridgeport Health Care Center
Bridgeport, Connecticut, 06610
Bridgeport Manor
Bridgeport, Connecticut, 06610
Riverside Health & Rehabilitation Center
East Hartford, Connecticut, 06108
Ludlowe Health Care Center
Fairfield, Connecticut, 06825
Glastonbury Health Care Center
Glastonbury, Connecticut, 06033
The Nathaniel Witherell
Greenwich, Connecticut, 06830
Arden House Care and Rehabilitation Center
Hamden, Connecticut, 06514
Hamden Health Care Center
Hamden, Connecticut, 06514
Avery Heights
Hartford, Connecticut, 06106
Wadsworth Glen Health Care and Rehabilitation Center
Middletown, Connecticut, 06457
Water's Edge Center for Health & Rehabilitation
Middletown, Connecticut, 06457
Grimes Center
New Haven, Connecticut, 06511
Mary Wade Home
New Haven, Connecticut, 06511
Advanced Nursing & Rehab Center of New Haven
New Haven, Connecticut, 06519
Shady Knoll Health Center
Seymour, Connecticut, 06483
Lord Chamberlain Nursing & Rehabilitation Center
Stratford, Connecticut, 06614
Village Green of Wallingford
Wallingford, Connecticut, 06492
Abbott Terrace Health Center
Waterbury, Connecticut, 06702
Hughes Health & Rehab Center
West Hartford, Connecticut, 06119
About this study
Official title: A Randomized, Controlled Trial of Cranberry Capsules for UTI Prevention in Nursing Home Residents
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.
- Conditions
- Bacteriuria
- Being tested
- 2 cranberry capsules, Placebo
- Medical subject headings
- Bacteriuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| 2 cranberry capsules | Active comparator | Experimental: 2 cranberry capsules Receives: Dietary Supplement: 2 cranberry capsules |
| 2 placebo capsules | Placebo comparator | Experimental: 2 placebo capsules qd Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One year
Secondary outcomes (7)
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.
Measured: One year
Number of Hospitalizations
Measured: One year
Number of Deaths
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for BacteriuriaStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomized to cranberry or placebo capsules.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Manisha Juthani-Mehta, M.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01691430
- Sponsor's protocol ID
- 1112009472
- Other IDs
- 2P30AG021342-11, 1R01AG041153-01A1
- Status last verified
- Mar 2020
- First submitted
- 9 Aug 2012
- Last updated
- 6 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Williams G, Stothart CI, Hahn D, Stephens JH, Craig JC, Hodson EM. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2023 Nov 10;11(11):CD001321. doi: 10.1002/14651858.CD001321.pub7.
PubMed 37947276Williams G, Hahn D, Stephens JH, Craig JC, Hodson EM. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2023 Apr 17;4(4):CD001321. doi: 10.1002/14651858.CD001321.pub6.
PubMed 37068952Datta 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.
PubMed 29696228Juthani-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.
PubMed 27787564
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Trial of Cranberry Capsules for UTI Prevention in Nursing Home Residents
- ClinicalTrials.gov ID
- NCT01691430
- Acronym / sponsor ID
- 1112009472
- Conditions
- Bacteriuria
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Aug 2012
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 24 Sep 2012 (estimated)
- Results
- Posted 29 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomized to cranberry or placebo capsules.
| Arm | Type | Receives |
|---|---|---|
| 2 cranberry capsules | Active comparator | Dietary Supplement: 2 cranberry capsulesExperimental: 2 cranberry capsules |
| 2 placebo capsules | Placebo comparator | Dietary Supplement: PlaceboExperimental: 2 placebo capsules qd |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- female residents;
- long term residents
- English speaking; and
- age ≥ 65 years.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2 cranberry capsulesTwo cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC) | Dietary supplement | 2 cranberry capsules |
| PlaceboTwo placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC) | Dietary supplement | 2 placebo capsules |
Primary outcome
Participants With Urine Cultures With Bacteriuria (>100,000 Cfu/ml or >=100,000 Cfu/ml) Plus Pyuria (Any WBC)
Time frame: One year
Clean catch urine cultures and urinalyses will be obtained every two months for each participant for study purposes.
7 secondary outcomes
Number of Episodes of Symptomatic UTI
Time frame: One year
Number of Hospitalizations
Time frame: One year
Number of Deaths
Time frame: One year
Number of Antibiotic Prescriptions
Time frame: One year
Bacteriuria With Multidrug-resistant Gram-negative Bacilli
Time frame: One year
Number of Antibiotic Prescriptions for Suspected UTI
Time frame: One Year
Subjects With 1, 2, or 3 Episodes of UTIs
Time frame: One year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37947276Williams G, Stothart CI, Hahn D, Stephens JH, Craig JC, Hodson EM. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2023 Nov 10;11(11):CD001321. doi: 10.1002/14651858.CD001321.pub7.
- Derived from this study: PubMed 37068952Williams G, Hahn D, Stephens JH, Craig JC, Hodson EM. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2023 Apr 17;4(4):CD001321. doi: 10.1002/14651858.CD001321.pub6.
- Derived from this study: PubMed 29696228Datta 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.
- Derived from this study: PubMed 27787564Juthani-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manisha Juthani-Mehta, M.D. principal investigator
Yale University
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 2 cranberry capsules in people with Bacteriuria, run by Yale University at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants With Urine Cultures With Bacteriuria (>100,000 Cfu/ml or >=100,000 Cfu/ml) Plus Pyuria (Any WBC) (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01691430, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2020.