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| ID | Type | Description | Link |
|---|---|---|---|
| 2P30AG021342-11 | U.S. NIH Grant/Contract | View source | |
| 1R01AG041153-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 cranberry capsules | Active Comparator | Experimental: 2 cranberry capsules |
|
| 2 placebo capsules | Placebo Comparator | Experimental: 2 placebo capsules qd |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2 cranberry capsules | Dietary Supplement | Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC) |
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| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events in Participants | One year | |
| Adherence to Capsule Intake by All Participants | measured by capsules removed from blister packs | One year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manisha Juthani-Mehta, M.D. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Branford Hills Health Care | Branford | Connecticut | 06405 | United States | ||
| Northbridge Health Care Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37947276 | Derived | 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. | |
| 37068952 | Derived | Williams 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. |
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806 patients were eligible, 558 declined to participate. Of the 248 consented, 63 were found to be ineligible after consent, leaving 185 to randomize.
Recruited from nursing homes within 50 miles of New Haven.
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| ID | Title | Description |
|---|---|---|
| FG000 | 2 Cranberry Capsules | Experimental: 2 cranberry capsules 2 cranberry capsules: Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC) |
| FG001 | 2 Placebo Capsules |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Participants were randomized to cranberry or placebo capsules.
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| Placebo | Dietary Supplement | Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC) |
|
| 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 |
| Bridgeport |
| Connecticut |
| 06606 |
| United States |
| Bridgeport Health Care Center | Bridgeport | Connecticut | 06610 | United States |
| Bridgeport Manor | Bridgeport | Connecticut | 06610 | United States |
| Riverside Health & Rehabilitation Center | East Hartford | Connecticut | 06108 | United States |
| Ludlowe Health Care Center | Fairfield | Connecticut | 06825 | United States |
| Glastonbury Health Care Center | Glastonbury | Connecticut | 06033 | United States |
| The Nathaniel Witherell | Greenwich | Connecticut | 06830 | United States |
| Arden House Care and Rehabilitation Center | Hamden | Connecticut | 06514 | United States |
| Hamden Health Care Center | Hamden | Connecticut | 06514 | United States |
| Avery Heights | Hartford | Connecticut | 06106 | United States |
| Wadsworth Glen Health Care and Rehabilitation Center | Middletown | Connecticut | 06457 | United States |
| Water's Edge Center for Health & Rehabilitation | Middletown | Connecticut | 06457 | United States |
| Grimes Center | New Haven | Connecticut | 06511 | United States |
| Mary Wade Home | New Haven | Connecticut | 06511 | United States |
| Advanced Nursing & Rehab Center of New Haven | New Haven | Connecticut | 06519 | United States |
| Shady Knoll Health Center | Seymour | Connecticut | 06483 | United States |
| Lord Chamberlain Nursing & Rehabilitation Center | Stratford | Connecticut | 06614 | United States |
| Village Green of Wallingford | Wallingford | Connecticut | 06492 | United States |
| Abbott Terrace Health Center | Waterbury | Connecticut | 06702 | United States |
| Hughes Health & Rehab Center | West Hartford | Connecticut | 06119 | United States |
| 29696228 | Derived | 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. |
| 27787564 | Derived | 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. |
Experimental: 2 placebo capsules qd
Placebo: Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)
| Received Medication |
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| COMPLETED |
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| NOT COMPLETED |
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Inclusion criteria were (1) female; (2) long-term care residents; (3) English speaking; and (4) 65 years or older.
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| ID | Title | Description |
|---|---|---|
| BG000 | 2 Cranberry Capsules | Experimental: 2 cranberry capsules 2 cranberry capsules: Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC) |
| BG001 | 2 Placebo Capsules | Experimental: 2 placebo capsules qd Placebo: Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Bacteriuria plus pyuria | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 147 subjects completed 1 year, 33 died. 20 subjects, 9 in the treatment group v 11 in the control group, became incontinent prior to the first time point, thus unable to provide any urine. 45 subjects stopped taking the capsules, 24 in treatment and 21 in control; 21 refused, 19 transitioned to hospice, 4 started warfarin, and 1 refused via family. | Posted | Number | participants | One year |
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| Secondary | 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. | Posted | Number | symptomatic urinary tract infections | One year |
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| Secondary | Number of Hospitalizations | Posted | Number | hospitilizations | One year |
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| Secondary | Number of Deaths | Posted | Number | participants | One year |
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| ||||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Number | prescriptions | One year |
|
| |||||||||||||||||||||||||||||||
| Secondary | 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). | Posted | Number | episodes | One year |
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| |||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Number | prescriptions | One Year |
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| Other Pre-specified | Number of Adverse Events in Participants | Posted | Number | adverse events | One year |
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| Other Pre-specified | Adherence to Capsule Intake by All Participants | measured by capsules removed from blister packs | Posted | Number | percentage of capsules | One year |
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| Secondary | 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. | There were 10 symptomatic UTIs in the treatment group (8 participants with 1 episode and 1 participant with 2 episodes) and 12 symptomatic UTIs in the control group (7 participants with 1 episode, 1 participant with 2 episodes, and 1 participant with 3 episodes). | Posted | Number | participants | One year |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 2 Cranberry Capsules | Experimental: 2 cranberry capsules 2 cranberry capsules: Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC) | 50 | 92 | 92 | 92 | ||
| EG001 | 2 Placebo Capsules | Experimental: 2 placebo capsules qd Placebo: Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC) | 66 | 93 | 93 | 93 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | General disorders | Systematic Assessment |
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| Death | General disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal blood glucose | Blood and lymphatic system disorders | Systematic Assessment |
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| Acute chest pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Acute renal failure | Renal and urinary disorders | Systematic Assessment |
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| Altered mental status | Psychiatric disorders | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Back Pain | General disorders | Systematic Assessment |
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| Blood pressure alteration | Blood and lymphatic system disorders | Systematic Assessment |
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| constipation | Gastrointestinal disorders | Systematic Assessment |
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| dehydration | General disorders | Systematic Assessment |
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| dizziness | Nervous system disorders | Systematic Assessment |
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| ear problem | Ear and labyrinth disorders | Systematic Assessment |
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| edema | General disorders | Systematic Assessment |
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| exposure to influenza | Infections and infestations | Systematic Assessment |
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| eye infection | Eye disorders | Systematic Assessment |
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| Fall | General disorders | Non-systematic Assessment |
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| fever | General disorders | Systematic Assessment |
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| GI disturbance | Gastrointestinal disorders | Systematic Assessment |
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| Generalized malaise | General disorders | Systematic Assessment |
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| headache | General disorders | Systematic Assessment |
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| insomnia | General disorders | Systematic Assessment |
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| joint pain | General disorders | Systematic Assessment |
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| lab abnormality | General disorders | Systematic Assessment |
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| leg pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| oral cavity disturbance | General disorders | Systematic Assessment |
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| respiratory difficulty | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| skin/soft tissue event | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Urinary Tract Infection | Renal and urinary disorders | Systematic Assessment |
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| weight gain | Metabolism and nutrition disorders | Systematic Assessment |
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| weight loss | Metabolism and nutrition disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Manisha Juthani-Mehta | Yale University | (203)785-4140 | manisha.juthani@yale.edu |
| ID | Term |
|---|---|
| D001437 | Bacteriuria |
| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| >=65 years |
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| Male |
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| Non-White |
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| 2 months |
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| 4 months |
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| 6 months |
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| 8 months |
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| 10 months |
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| 12 months |
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