Overview

Clinical Effectiveness and Bacteriological Eradication of 4 Short-course Antibiotics for Uncomplicated UTIs in Women.

Status:
Not yet recruiting

Trial end date:
2023-05-30

Target enrollment:

Participant gender:

Summary

Randomized clinical trial in which women aged 18 or older and with symptoms of uncomplicated lower urinary tract infection and a positive urine dipstick analysis will be randomized to one of the following four groups: 2-day 3 g fosfomycin o.d., 3-day pivmecillinam 400 mg. t.i.d, 5-day nitrofurantoin 100 mg t.i.d. or a single dose of 3 g of fosfomycin. Sample: 1,000 patients. Two co-primary endpoints are considered: clinical effectiveness at day 7 and bacteriological eradication at day 14. Follow-up visits are scheduled at days 7 (phone call), 14 and 28 for assessing evolution. Urine samples will be collected in the three on-site visits and urine cultures performed.

Phase:

Phase 4

Details

Lead Sponsor:

Jordi Gol i Gurina Foundation

Collaborators:

Balearic Islands Health Service (Ibsalut)
Gerencia de Atención Primaria, Madrid
Instituto de Investigación Sanitaria Aragón

Treatments:

Amdinocillin Pivoxil
Fosfomycin
Nitrofurantoin