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

HaEmek Medical Center, Israel

Status and phase: Withdrawn; Phase 4

Conditions: Cystitis

Treatments: Drug: NITROFURANTOIN MACROCRYSTALS

Study type: Interventional

Funder types: Other

Identifiers

NCT00361998

0706

Details and patient eligibility

About

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 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.

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)