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
  Purpose

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 They will then be treated with another standard antibiotic at no cost to them and will be withdrawn from the study at that time.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


Condition Intervention Phase
Urinary Tract Infection
Drug: Nitrofurantoin 100mg twice daily x 5 days
Drug: TMP/SMX DS twice daily x 3 days
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Short Course Nitrofurantoin For Acute Cystitis

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Microbiological Cure [ Time Frame: 28-30 days post therapy ] [ Designated as safety issue: No ]

Enrollment: 338
Study Start Date: January 2002
Study Completion Date: July 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Nitrofurantoin 100mg BID x 5 days
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: 2
TMP/SMX DS BID x 3 days
Drug: TMP/SMX DS twice daily x 3 days
TMP/SMX DS twice daily x 3 days
Other Name: Septra

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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00391651

Locations
United States, Washington
University of WA
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Procter and Gamble
Investigators
Principal Investigator: Walter E Stamm, M.D. University of Washington
Principal Investigator: Kalpana Gupta, M.D. Yale University
  More Information

Publications:
Responsible Party: Ann Stapleton, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT00391651     History of Changes
Other Study ID Numbers: 20580-A, 01-1002-A 07
Study First Received: October 20, 2006
Last Updated: June 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
UTI

Additional relevant MeSH terms:
Cystitis
Urinary Tract Infections
Urinary Bladder Diseases
Urologic Diseases
Infection
Nitrofurantoin
Anti-Infective Agents, Urinary
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Renal Agents

ClinicalTrials.gov processed this record on July 29, 2014