Short Course Nitrofurantoin for Acute Cystitis

Overview

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 They will then be treated with another standard antibiotic at no cost to them and will be withdrawn from the study at that time.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.

Full Title of Study: “Short Course Nitrofurantoin For Acute Cystitis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2005

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.

Interventions

  • Drug: Nitrofurantoin 100mg twice daily x 5 days
    • Nitrofurantoin 100mg twice daily x 5 days
  • Drug: TMP/SMX DS twice daily x 3 days
    • TMP/SMX DS twice daily x 3 days

Arms, Groups and Cohorts

  • Active Comparator: 1
    • Nitrofurantoin 100mg BID x 5 days
  • Active Comparator: 2
    • TMP/SMX DS BID x 3 days

Clinical Trial Outcome Measures

Primary Measures

  • Microbiological Cure
    • Time Frame: 28-30 days post therapy

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Washington
  • Collaborator
    • Procter and Gamble
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ann Stapleton, Professor – University of Washington
  • Overall Official(s)
    • Walter E Stamm, M.D., Principal Investigator, University of Washington
    • Kalpana Gupta, M.D., Principal Investigator, Yale University

Citations Reporting on Results

Gupta K, Hooton TM, Roberts PL, Stamm WE. Short-course nitrofurantoin for the treatment of acute uncomplicated cystitis in women. Arch Intern Med. 2007 Nov 12;167(20):2207-12.

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