Nitrofurantoin Macrocrystals 3 Days Versus 7 Days in the Treatment of Women With Uncomplicated Cystitis
Information source: HaEmek Medical Center, Israel
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cystitis
Intervention: NITROFURANTOIN MACROCRYSTALS (Drug)
Phase: Phase 4
Status: Withdrawn
Sponsored by: HaEmek Medical Center, Israel Official(s) and/or principal investigator(s):
Raul Raz, M.D., Principal Investigator, Affiliation: Infectious Diseases Unit, HaEmek Medical Center, Afula, Israel
Uzi Milman, M.D., Principal Investigator, Affiliation: Research Unit, Clalit Health Services, Haifa and Western-Galilee District, Israel.
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.
Clinical Details
Official title: Nitrofurantoin Macrocrystals 3 Days Vs. 7 Days in the Treatment of Women With Uncomplicated Cystitis
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Microbiological efficacy
Secondary outcome: Clinical efficacy and side effects
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
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Female.
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
Locations and Contacts
Research Unit, Clalit Health Services, Haifa and Western Galillee District, Haifa 35024, Israel
Additional Information
Starting date: September 2006
Last updated: March 1, 2007
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