Ignite Creation Date:
2024-05-05 @ 9:50 PM
Last Modification Date:
2024-10-26 @ 10:10 AM
Study NCT ID:
NCT00976963
Status:
COMPLETED
Last Update Posted:
2023-06-05
First Post:
2009-09-11
Brief Title:
Single Dose Monurol for Treatment of Acute Cystitis
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Single Dose Monurol for Treatment of Acute Cystitis
Status:
COMPLETED
Status Verified Date:
2023-06
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:
None
Brief Summary:
Urinary tract infecton UTI is a very common problem in young healthy women afflicting approximately one-half of women by their late 20s One of the most common antibiotics used to treat UTIs is Trimethoprim-Sulfamethoxazole TMP-SMX usually for total of three days However concerns about increased antibiotic resistance have led to increased interest in studying other antibiotics for UTI
An alternative antibiotic which is also FDA approved for the treatment of UTIs is fosfomycin Monurol The effectiveness of fosfomycin in curing UTIs when given as a single dose is not well studied The purpose of this research study is to determine what the cure rates are with a single dose of fosfomycin versus the more standard 3-day course of TMP-SMX
An alternative antibiotic which is also FDA approved for the treatment of UTIs is fosfomycin Monurol The effectiveness of fosfomycin in curing UTIs when given as a single dose is not well studied The purpose of this research study is to determine what the cure rates are with a single dose of fosfomycin versus the more standard 3-day course of TMP-SMX
Detailed Description:
Procedures subjects will undergo once they have read and signed the consent are
Questions about their medical and sexual history and current symptoms of UTI They will be asked to provide a urine and peri-urethral sample and then are randomly assigned to one of the two treatment groupsThey will be given a sheet to record symptoms at home They will be asked to return to the clinic in 5-8 and 28-30 days after completing antibiotic therapyFollow-up questions will be asked and urine and peri-urethral will be self collected at each visit
Questions about their medical and sexual history and current symptoms of UTI They will be asked to provide a urine and peri-urethral sample and then are randomly assigned to one of the two treatment groupsThey will be given a sheet to record symptoms at home They will be asked to return to the clinic in 5-8 and 28-30 days after completing antibiotic therapyFollow-up questions will be asked and urine and peri-urethral will be self collected at each visit
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