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

Phase 4
Withdrawn
Conditions
Cystitis
Registration Number
NCT00361998
Lead Sponsor
HaEmek Medical Center, Israel
Brief Summary

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.

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.

Recruitment & Eligibility

Status
WITHDRAWN
Sex
Female
Target Recruitment
400
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Microbiological efficacy
Secondary Outcome Measures
NameTimeMethod
Clinical efficacy and side effects

Trial Locations

Locations (1)

Research Unit, Clalit Health Services, Haifa and Western Galillee District

🇮🇱

Haifa, Israel

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