Ignite Creation Date:
2024-05-05 @ 9:05 PM
Last Modification Date:
2024-10-26 @ 9:58 AM
Study NCT ID:
NCT00801021
Status:
COMPLETED
Last Update Posted:
2010-03-08
First Post:
2008-12-02
Brief Title:
Treatment andor Prevention of Urinary Tract Infections
Sponsor:
Biomedical Development Corporation
Organization:
Biomedical Development Corporation
Study Overview
Official Title:
Treatment andor Prevention of Urinary Tract Infections
Status:
COMPLETED
Status Verified Date:
2009-11
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:
UTI
Brief Summary:
The purpose of the study is to determine the effect of an investigational oral rinse in reducing uropathogens and treating uncomplicated urinary tract infections
Detailed Description:
A 7-day treatment with a 28-day follow up has been designed as a before and after assessment of the clinical signs and symptoms of an uncomplicated urinary tract infection and the reductioneradication of urinary pathogens Enrollment is targeted to achieving 20 evaluable subjects by the end of the study After enrolling in the trial at Day 0 first day of dosing participants will report back to the study site at Days 3 7 and 28 At Day 3 or any time thereafter worsening of symptoms andor increases in quantitative bacteria counts will result in removal from the trial and prescription of a rescue medication which will be selected based on microbial susceptibility testing
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 |
|---|---|---|---|
| 1R41DK082089-01 | NIH | None | httpsreporternihgovquickSearch1R41DK082089-01 |