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

This study has been withdrawn prior to enrollment.
(recruitment failed)
Sponsor:
Collaborator:
Clalit Health Services
Information provided by:
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT00361998
First received: August 8, 2006
Last updated: March 1, 2007
Last verified: March 2007
  Purpose

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.


Condition Intervention Phase
Cystitis
Drug: NITROFURANTOIN MACROCRYSTALS
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Nitrofurantoin Macrocrystals 3 Days Vs. 7 Days in the Treatment of Women With Uncomplicated Cystitis

Resource links provided by NLM:


Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • Microbiological efficacy

Secondary Outcome Measures:
  • Clinical efficacy and side effects

Estimated Enrollment: 400
Study Start Date: September 2006
Estimated Study Completion Date: January 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00361998

Locations
Israel
Research Unit, Clalit Health Services, Haifa and Western Galillee District
Haifa, Israel, 35024
Sponsors and Collaborators
HaEmek Medical Center, Israel
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.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00361998     History of Changes
Other Study ID Numbers: 0706
Study First Received: August 8, 2006
Last Updated: March 1, 2007
Health Authority: Israel: Ethics Commission

Keywords provided by HaEmek Medical Center, Israel:
Uncomplicated Cystitis
Nitrofurantoin Macrocrystals

Additional relevant MeSH terms:
Cystitis
Urinary Bladder Diseases
Urologic Diseases
Nitrofurantoin
Anti-Infective Agents, Urinary
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Renal Agents

ClinicalTrials.gov processed this record on September 16, 2014