Clinical trial

Single Dose Monurol for Treatment of Acute Cystitis

Name
34776
Description
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.
Trial arms
Trial start
2009-09-17
Estimated PCD
2016-12-27
Trial end
2016-12-27
Status
Completed
Treatment
TMP/SMX
Take one twice daily for 3 days for urinary tract infection
Arms:
TMP/SMX
Other names:
Septra, Bactrim
Fosfomycin
Mix sachet with 1/2 glass cold water and stir. Drink immediately
Arms:
Fosfomycin
Other names:
Monurol
Size
300
Primary endpoint
Number of Participants Who Were Cured
28-30 days post therapy
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 300, 'type': 'ACTUAL'}}
Updated at
2023-06-05

1 organization

2 products

1 indication

Product
TMP/SMX
Product
Fosfomycin