Short Course Nitrofurantoin for Acute Cystitis
Information source: University of Washington
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Urinary Tract Infection
Intervention: Nitrofurantoin 100mg twice daily x 5 days (Drug); TMP/SMX DS twice daily x 3 days (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: University of Washington Official(s) and/or principal investigator(s): Walter E Stamm, M.D., Principal Investigator, Affiliation: University of Washington Kalpana Gupta, M.D., Principal Investigator, Affiliation: Yale University
Summary
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antibiotic at no cost to them and will be withdrawn from the study at that time.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.
Clinical Details
Official title: Short Course Nitrofurantoin For Acute Cystitis
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Microbiological Cure
Detailed description:
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. The randomization is generated by a Research Scientist working with the study.
They will be given a sheet to record symptoms at home. They will be asked to return to the
clinic in 5-9 and 28-30 days after completing antibiotic therapy. Urine cultures 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Locations and Contacts
University of WA, Seattle, Washington 98195, United States
Additional Information
Starting date: January 2002
Last updated: June 3, 2014
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