N/A
Completed N=300
Single Dose Monurol for Treatment of Acute Cystitis
Source: ClinicalTrials.gov NCT00976963 ↗Enrolled (actual)
300
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcomePrimary: Number of Participants Who Were Cured — 120; 130 Participants — p=<0.001
Summary
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-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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Were Cured |
120; 130 | <0.001 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00976963). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.