At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Clinical Effectiveness and Bacteriological Eradication of Three Different Short-course Antibiotic Regimens and Single-dose Fosfomycin for Uncomplicated Lower Urinary Tract Infections in Adult Women.
In Brief
A Phase 4 clinical trial evaluating Fosfomycin Trometamol Salt, Nitrofurantoin, and 1 other intervention for Urinary Tract Infections. Completed, enrolled 1,000 participants across 33 sites.
Detailed 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.
Study Details
Timeline
Interventions
Fosfomycin 3 g 2 sachets, taken orally, once daily for two days
Nitrofurantoin 50 mg pills, taken orally, two pills/8 hours, for five days
Pivmecillinam 400 mg pills. taken orally, one pill/8 hours, for three days
Fosfomycin 3 g one sachet, taken orally, for one day