Single Dose Monurol for Treatment of Acute Cystitis
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Urology, Urology, Urinary Tract Infections |
| Therapuetic Areas: | Nephrology / Urology, Other |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 11/18/2017 |
| Start Date: | September 2009 |
| End Date: | May 30, 2018 |
Urinary tract infecton (UTI) is a very common problem in young healthy women, afflicting
approximately one-half of women by their late 20's. One of the most common antibiotics used
to treat UTIs is Trimethoprim-sulfa (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.
approximately one-half of women by their late 20's. One of the most common antibiotics used
to treat UTIs is Trimethoprim-sulfa (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.
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 groups.They 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
therapy.Follow-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 groups.They 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
therapy.Follow-up questions will be asked and urine and peri-urethral will be self collected
at each visit.
Inclusion Criteria:
- Non pregnant women in good health with symptoms of acute cystitis for less than 7 days
Exclusion Criteria:
- Pregnant, lactating, or not regularly contracepting
- History of chronic conditions such as diabetes
- Known anatomic abnormalities of the urinary tract
- Use of prophylactic antibiotics
- History of allergy or intolerance to any of the study drugs
- Recent (> 2 weeks)exposure to oral or parenteral antimicrobial
- History of UTI in previous 1 month
We found this trial at
1
site
Seattle, Washington 98104
(206) 543-2100
Principal Investigator: Ann E Stapleton, M.D.
Phone: 206-685-1048
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
Click here to add this to my saved trials
