Short Course Nitrofurantoin for Acute Cystitis
Completed · Phase 2
Conditions studied: Urinary Tract Infection
In brief
The purpose of this research study is to determine what the cure rates are with a 5 day course of nitrofurantoin versus the more standard 3 day course of trimethoprim/sulfamethoxazone. The study will improve our knowledge of which antibiotic and what length of therapy is best for treatment of UTI, taking into account the problem of antibiotic resistance. 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 sample and then randomly assigned to one of the two treatment groups. will be obtained at each visit. If they were assigned to the nitrofurantoin treatment regimen, they will also be asked to collect a urine sample at home on the third day. If the subject develops recurrent urinary symptoms or does not have resolution of symptoms after completing the initial treatment course, they will be asked to return to the clinic and provide another urine sample for analysis. They will then be treated with another standard antibiotic at no cost to them and will be withdrawn from the study at that time. The study population is women ages 18-45 with acute symptoms of a UTI without a history of UTI in the past 6 weeks.
Key facts
- Study ID
- NCT00391651
- Run by
- University of Washington
- People needed
- 338
- Starts
- 2002-01-01
- Expected to finish
- 2005-07-01
- Last updated by the study team
- 2014-06-05
Who can join
Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Women 18-45 years of age who were nonpregnant, in good general health, and had symptoms of acute cystitis (dysuria) and a urine culture with ³102 cfu/ml of a uropathogen
You may not qualify if…
- Women who were pregnant, lactating, or not regularly contracepting or with diabetes, had known anatomic abnormalities of the urinary tract, allergy to any of the study drugs, recent (<2 weeks) exposure to an oral or parenteral antimicrobial, or who were currently using prophylactic antibiotics were not eligible
Where it is running
- University of WA — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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