Cystitis
Conditions
Keywords
Uncomplicated Cystitis, Nitrofurantoin Macrocrystals
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.
Interventions
DRUGNITROFURANTOIN MACROCRYSTALS
Sponsors
Clalit Health Services
HaEmek Medical Center, Israel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Microbiological efficacy | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical efficacy and side effects | — |
Countries
Israel
Outcome results
None listed