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

Overview

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.

Full Title of Study: “Nitrofurantoin Macrocrystals 3 Days Vs. 7 Days in the Treatment of Women With Uncomplicated Cystitis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)

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.

Interventions

  • Drug: NITROFURANTOIN MACROCRYSTALS

Clinical Trial Outcome Measures

Primary Measures

  • Microbiological efficacy

Secondary Measures

  • Clinical efficacy and side effects

Participating 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: Female

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • HaEmek Medical Center, Israel
  • Collaborator
    • Clalit Health Services
  • Overall Official(s)
    • Raul Raz, M.D., Principal Investigator, Infectious Diseases Unit, HaEmek Medical Center, Afula, Israel
    • Uzi Milman, M.D., Principal Investigator, Research Unit, Clalit Health Services, Haifa and Western-Galilee District, Israel.

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