Short Course Nitrofurantoin for Acute Cystitis

This study has been completed.
Sponsor:
Collaborator:
Procter and Gamble
Information provided by (Responsible Party):
Ann Stapleton, University of Washington
ClinicalTrials.gov Identifier:
NCT00391651
First received: October 20, 2006
Last updated: June 3, 2014
Last verified: June 2014

October 20, 2006
June 3, 2014
January 2002
July 2005   (final data collection date for primary outcome measure)
Microbiological Cure [ Time Frame: 28-30 days post therapy ] [ Designated as safety issue: No ]
  • Microbiological Cure
  • Clinical Cure
Complete list of historical versions of study NCT00391651 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Short Course Nitrofurantoin for Acute Cystitis
Short Course Nitrofurantoin For Acute Cystitis

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 They will then be treated with another standard antibiotic at no cost to them and will be withdrawn from the study at that time.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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Urinary Tract Infection
  • Drug: Nitrofurantoin 100mg twice daily x 5 days
    Nitrofurantoin 100mg twice daily x 5 days
    Other Name: Macrobid
  • Drug: TMP/SMX DS twice daily x 3 days
    TMP/SMX DS twice daily x 3 days
    Other Name: Septra
  • Active Comparator: 1
    Nitrofurantoin 100mg BID x 5 days
    Interventions:
    • Drug: Nitrofurantoin 100mg twice daily x 5 days
    • Drug: TMP/SMX DS twice daily x 3 days
  • Active Comparator: 2
    TMP/SMX DS BID x 3 days
    Intervention: Drug: TMP/SMX DS twice daily x 3 days
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
338
July 2005
July 2005   (final data collection date for primary outcome measure)

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
Female
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00391651
20580-A, 01-1002-A 07
No
Ann Stapleton, University of Washington
University of Washington
Procter and Gamble
Principal Investigator: Walter E Stamm, M.D. University of Washington
Principal Investigator: Kalpana Gupta, M.D. Yale University
University of Washington
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP