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Cranberry for UTI Prevention in Residents of Long Term Care Facilities (PACS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00596635
First received: January 8, 2008
Last updated: March 19, 2013
Last verified: March 2013
History of Changes
Results First Received: June 30, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Urinary Tract Infection
Interventions: Dietary Supplement: Once Daily Cranberry Capsule
Dietary Supplement: Twice Daily Cranberry Capsules

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Four dementia units participated in this study. Exclusion criteria included: 1)indwelling catheter, 2)residence <4 weeks, 3)prednisone therapy, 4)active UTI symptoms, 5)terminal, 6)end stage renal disease, 7)<60 years old, 8)chronic suppressive antibiotic therapy, 9)history of kidney stones, 10)unable to provide baseline urine, 11)warfarin therapy.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
If a participant could not provide a baseline urine specimen or met an exclusion criterion prior to group assignment but after consent, he or she was not enrolled.

Reporting Groups
  Description
No Cranberry Capsules Control Group No Cranberry Capsule
One Cranberry Capsule 1 650mg cranberry capsule daily
2 Cranberry Capsules 1 650 mg cranberry capsule twice daily (bid)

Participant Flow:   Overall Study
    No Cranberry Capsules     One Cranberry Capsule     2 Cranberry Capsules  
STARTED     17     20     19  
COMPLETED     10     7     11  
NOT COMPLETED     7     13     8  
Lost to Follow-up                 0                 2                 0  
Treatment for symptomatic UTI                 4                 6                 3  
Hip fracture                 2                 3                 3  
Could not provide urine specimen                 1                 2                 2  



  Baseline Characteristics
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Reporting Groups
  Description
No Cranberry Capsules Control Group No Cranberry Capsule
One Cranberry Capsule 1 650mg cranberry capsule daily
2 Cranberry Capsules 1 650 mg cranberry capsule twice daily (bid)
Total Total of all reporting groups

Baseline Measures
    No Cranberry Capsules     One Cranberry Capsule     2 Cranberry Capsules     Total  
Number of Participants  
[units: participants]
 		  17     20     19     56  
Age  
[units: participants]
 		       
<=18 years     0     0     0     0  
Between 18 and 65 years     1     0     0     1  
>=65 years     16     20     19     55  
Age  
[units: years]
Mean ± Standard Deviation 		  85.76  ± 11.76     88.30  ± 6.16     86.68  ± 5.16     86.82  ± 7.97  
Gender  
[units: participants]
 		       
Female     13     17     16     46  
Male     4     3     3     10  
Region of Enrollment  
[units: participants]
 		       
United States     17     20     19     56  



  Outcome Measures
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1.  Primary:   Number of Urine Cultures Collected Out of the Total Number Expected to be Collected.   [ Time Frame: 6 months ]

Measure Type Primary
Measure Title Number of Urine Cultures Collected Out of the Total Number Expected to be Collected.
Measure Description Urine cultures were collected at baseline and monthly for six months. The total number of urine cultures collected out of the total number that were expected to be collected are shown.
Time Frame 6 months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
No Cranberry Capsules Control Group No Cranberry Capsule
One Cranberry Capsule 1 650mg cranberry capsule daily
2 Cranberry Capsules 1 650 mg cranberry capsule twice daily (bid)

Measured Values
    No Cranberry Capsules     One Cranberry Capsule     2 Cranberry Capsules  
Number of Participants Analyzed  
[units: participants]
 		  17     20     19  
Number of Urine Cultures Collected Out of the Total Number Expected to be Collected.  
[units: Urine cultures]
 		     
Number of urine cultures expected     81     74     85  
Number of urine cultures collected     73     63     71  

No statistical analysis provided for Number of Urine Cultures Collected Out of the Total Number Expected to be Collected.



2.  Secondary:   Number of Participants With E.Coli Isolated From Urine Culture   [ Time Frame: 6 months ]

Measure Type Secondary
Measure Title Number of Participants With E.Coli Isolated From Urine Culture
Measure Description Urine cultures were obtained at baseline and monthly for six months. Any participant that had E.coli isolated at least once is listed as meeting the outcome.
Time Frame 6 months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
No Cranberry Capsules Control Group No Cranberry Capsule
One Cranberry Capsule 1 650mg cranberry capsule daily
2 Cranberry Capsules 1 650 mg cranberry capsule twice daily (bid)

Measured Values
    No Cranberry Capsules     One Cranberry Capsule     2 Cranberry Capsules  
Number of Participants Analyzed  
[units: participants]
 		  17     20     19  
Number of Participants With E.Coli Isolated From Urine Culture  
[units: Participants]
 		  8     8     12  

No statistical analysis provided for Number of Participants With E.Coli Isolated From Urine Culture



3.  Secondary:   Number of Participants With >100,000 Colony Forming Units Per Milliliter of Any Organism Isolated From Urine Culture   [ Time Frame: 6 months ]

Measure Type Secondary
Measure Title Number of Participants With >100,000 Colony Forming Units Per Milliliter of Any Organism Isolated From Urine Culture
Measure Description Urine cultures were obtained at baseline and monthly for 6 months. If a urine culture had >100,000 colony forming units per milliliter of any organism on any of the urine cultures obtained, the participant is noted as meeting the outcome.
Time Frame 6 months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
No Cranberry Capsules Control Group No Cranberry Capsule
One Cranberry Capsule 1 650mg cranberry capsule daily
2 Cranberry Capsules 1 650 mg cranberry capsule twice daily (bid)

Measured Values
    No Cranberry Capsules     One Cranberry Capsule     2 Cranberry Capsules  
Number of Participants Analyzed  
[units: participants]
 		  17     20     19  
Number of Participants With >100,000 Colony Forming Units Per Milliliter of Any Organism Isolated From Urine Culture  
[units: Participants]
 		  12     13     14  

No statistical analysis provided for Number of Participants With >100,000 Colony Forming Units Per Milliliter of Any Organism Isolated From Urine Culture




  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The inability to follow all participants for the full six months reflects the vulnerability of the population.  


Results Point of Contact:  
Name/Title: Manisha Juthani-Mehta, MD
Organization: Yale University School of Medicine
phone: (203)785-4140
e-mail: manisha.juthanimehta@yale.edu


Publications of Results:


Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00596635     History of Changes
Other Study ID Numbers: 0606001581, DF06-005
Study First Received: January 8, 2008
Results First Received: June 30, 2010
Last Updated: March 19, 2013
Health Authority: United States: Institutional Review Board