Ignite Creation Date:
2024-05-05 @ 7:02 PM
Last Modification Date:
2024-10-26 @ 9:42 AM
Study NCT ID:
NCT00596635
Status:
COMPLETED
Last Update Posted:
2013-03-29
First Post:
2008-01-08
Brief Title:
Cranberry for UTI Prevention in Residents of Long Term Care Facilities
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Cranberry for UTI Prevention in Residents of Long Term Care Facilities
Status:
COMPLETED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PACS
Brief Summary:
Urinary tract infections UTIs affect over 7 million men and women per year and cost the health care industry over 1 billion dollars annually The incidence of UTI increases markedly in elderly institutionalized persons and leads to excessive antimicrobial usage emergency room visits hospitalization sepsis and death The use of antimicrobials to prevent UTI in elderly nursing home patients is not recommended and is fraught with problems such as adverse reactions drug interactions and the development of drug-resistant organisms There is no accepted method of preventing UTI in residents of nursing homes a vulnerable and understudied population with significant morbidity from UTI
The overall goal of this proposal is to conduct a prospective cohort pilot study that evaluates the feasibility of using cranberry to prevent UTI in nursing home residents Each of the aims is critical for the optimal design of a larger placebo-controlled definitive trial of cranberry for prevention of UTI in nursing home residents and will provide the essential preliminary data for future larger studies
The overall goal of this proposal is to conduct a prospective cohort pilot study that evaluates the feasibility of using cranberry to prevent UTI in nursing home residents Each of the aims is critical for the optimal design of a larger placebo-controlled definitive trial of cranberry for prevention of UTI in nursing home residents and will provide the essential preliminary data for future larger studies
Detailed Description:
Cranberry products represent a novel non-antimicrobial method for prevention of UTI There is evidence for a plausible mechanism and efficacy for UTI prevention in healthy premenopausal women Limited clinical studies of cranberry products in elderly men and women have demonstrated reductions in bacteriuria but have not been of adequate size or quality to support the use of cranberry in this population or result in changes in patient care Thus a properly designed definitive study demonstrating efficacy of cranberry in preventing UTI in this population is needed However before a large-scale placebo-controlled trial can be justified the complexities inherent to studying older nursing home residents need to be addressed These include issues related to collecting uncontaminated urine samples understanding the microbiology of UTI in this population and devising an acceptable intervention regimen The overall goal of this proposal is to conduct a prospective cohort pilot study that evaluates the feasibility of using cranberry to prevent UTI in nursing home residents Each of the aims listed below is critical for the optimal design of a larger placebo-controlled definitive trial of cranberry for prevention of UTI in nursing home residents and will provide the essential preliminary data for a future RO1 level grant application
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DF06-005 | None | None | None |