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NCT00391651 · ClinicalTrials.gov registry record · Phase 2

Short Course Nitrofurantoin for Acute Cystitis

A Phase 2 study of Urinary Tract Infection, sponsored by University of Washington.

Completed
Registry status
Phase 2
Development phase
338
Enrollment target
1
Study location

NCT00391651: Completed Phase 2 study of Urinary Tract Infection, sponsored by University of Washington.

NCT00391651 is a Phase 2 study of Urinary Tract Infection that has completed, run by University of Washington. The registered enrollment target is 338 participants, below the 643-participant average among 11 other Urinary Tract Infection trials with a reported enrollment target (47% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00391651, a Phase 2 study of Urinary Tract Infection, has completed, sponsored by University of Washington.

COMPLETED
Registry status
Phase 2
Development phase
338 participants
Enrollment target
1
Study location

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 They will then be treated with another standard antibiotic at no cost to them and will be withdrawn from the study at that time.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

Conditions Studied

Interventions

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

Study Locations (1)

Washington

  • University of WA - Seattle

Trial Details

FieldValue
Enrollment Target 338 participants
Start Date 2002-01
Est. Completion 2005-07
Phase Phase 2
University of Washington

1,048 total trials

What the finished NCT00391651 record still lists

NCT00391651 is an interventional study that assigns participants to a tested intervention. The registered 338 participants enrollment target is mid-sized for trials with a published cap, below the 643-participant average among 11 other Urinary Tract Infection trials with a reported enrollment target (47% lower).

The record links to 1 condition, with Urinary Tract Infection appearing as the primary indexed condition, and to 2 interventions - of which Nitrofurantoin 100mg twice daily x 5 days is the first listed.

NCT00391651 reports a single indexed study location in Washington.

Frequently Asked Questions

What is clinical trial NCT00391651 about?

NCT00391651 is a clinical study titled "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, t...

What is the current status of trial NCT00391651?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 338 participants. The study started on 2002-01. Estimated completion is 2005-07.

What conditions does trial NCT00391651 study?

This clinical trial studies the following conditions: Urinary Tract Infection.

What interventions are being tested in trial NCT00391651?

The interventions under investigation include: Nitrofurantoin 100mg twice daily x 5 days (DRUG), TMP/SMX DS twice daily x 3 days (DRUG).

Who is sponsoring clinical trial NCT00391651?

This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00391651 being conducted?

This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Urinary Tract Infection

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00391651's enrollment target sits among peer trials

338 5th of 11 higher than 7 of 11 other Urinary Tract Infection trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Urinary Tract Infection trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00391651, the US trial registry maintained by the National Library of Medicine. NCT00391651 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.