Nitrofurantoin Macrocrystals 3 Days Versus 7 Days in the Treatment of Women With Uncomplicated Cystitis

March 1, 2007 updated by: HaEmek Medical Center, Israel

Nitrofurantoin Macrocrystals 3 Days Vs. 7 Days in the Treatment of Women With Uncomplicated Cystitis

Our guidelines in the community recommend the use of NM for the treatment of women with community acquired UTI. While the length of treatment for uncomplicated cystitis with quinolones or TMP-SMX is three days, NM is recommended for seven days. However, there are not sufficient papers that establish the optimal length of treatment with NM in this population. The aim of this proposal is to evaluate and compare NM 3 day vs. 7 day treatment for the treatment of women with uncomplicated UTI.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The aim of this proposal is to evaluate and compare NM 3 day vs. 7 day treatment for the treatment of women with uncomplicated UTI. Our design is to enroll 400 women with uncomplicated cystitis and divided according to a double-blind randomization in two groups (3 days vs. 7 days). The women will be followed 7 days and 28 days clinically and bacteriologically.

Study Type

Interventional

Enrollment

400

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel, 35024
        • Research Unit, Clalit Health Services, Haifa and Western Galillee District

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Premenopausal healthy women
  2. Uncomplicated cystitis

Exclusion Criteria:

  1. Postmenopausal women
  2. Complicated UTI
  3. Women with catheter
  4. Women with recurrent UTI
  5. Pregnancy
  6. Diabetes Mellitus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Microbiological efficacy

Secondary Outcome Measures

Outcome Measure
Clinical efficacy and side effects

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HaEmek Medical Center, Israel

Collaborators

Clalit Health Services

Investigators

  • Principal Investigator: Raul Raz, M.D., Infectious Diseases Unit, HaEmek Medical Center, Afula, Israel
  • Principal Investigator: Uzi Milman, M.D., Research Unit, Clalit Health Services, Haifa and Western-Galilee District, Israel.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Study Completion

January 1, 2007

Study Registration Dates

First Submitted

August 8, 2006

First Submitted That Met QC Criteria

August 8, 2006

First Posted (ESTIMATE)

August 9, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

March 2, 2007

Last Update Submitted That Met QC Criteria

March 1, 2007

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0706

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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