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...
Date First Received: August 8, 2006
Last Updated: March 1, 2007
Verified by: HaEmek Medical Center, Israel, March 2007
Clinical Trial Phase: Phase 4 | Start Date: September 2006
Overall Status: Withdrawn
Estimated Enrollment: 400
Brief Summary
Official Title: “Nitrofurantoin Macrocrystals 3 Days Vs. 7 Days in the Treatment of Women With Uncomplicated Cystitis”
Condition Keyword(s):
Intervention(s):
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 Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Bio-equivalence Study
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Drug: NITROFURANTOIN MACROCRYSTALS
Outcome Measures for this Clinical Trial
Primary Measures
- Microbiological efficacy
Secondary Measures
- Clinical efficacy and side effects
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 55 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: HaEmek Medical Center, Israel
Overall Clinical Trial Officials and Contacts
Raul Raz, M.D. Principal Investigator Infectious Diseases Unit, HaEmek Medical Center, Afula, Israel
Additional Information
Information obtained from ClinicalTrials.gov on September 04, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00361998
Study ID Number: 0706
ClinicalTrials.gov Identifier: NCT00361998
Health Authority: Israel: Ethics Commission
Clinical Trials Authorship and Review
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