Short Course Nitrofurantoin for Acute Cystitis
Condition: Urinary Tract Infection
MeSH terms: Urinary Tract Infections; Cystitis
Study type: Interventional
Phase: Phase 2

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      antibiotic at no cost to them and will be withdrawn from the study at that time.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.
    

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.
    

Intervention name(s): Nitrofurantoin 100mg twice daily x 5 days; TMP/SMX DS twice daily x 3 days
Intervention type(s): Drug; Drug
Intervention description(s): Nitrofurantoin 100mg twice daily x 5 days; TMP/SMX DS twice daily x 3 days
Other intervention name(s): Macrobid; Septra
Intervention MeSH terms: Nitrofurantoin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: UTI