drugset / Trial / NCT04959331
Clinical Effectiveness and Bacteriological Eradication of 4 Short-course Antibiotics for Uncomplicated UTIs in Women.
Phase 4
Completed
1000 enrolled
Jordi Gol Institute for Primary Care Research
Balearic Islands Health Service (Ibsalut) · collabGerencia de Atención Primaria, Madrid · collabInstituto de Investigación Sanitaria Aragón · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2021-11-02
- Primary completion
- 2024-12-14
- Completion
- 2024-12-31
Publications
- Llor C, Monfa R, Garcia-Sangenis A, Leiva A, Marin-Canada J, Sanchez-Calavera MA, Moragas A, Aguilar-Sanchez M, Troncoso-Marino A, Rodriguez-Barrientos R, Molero JM, Ouchi D, Miranda-Jimenez C, Fernandez-Garcia S, Morros R. Clinical and bacteriological effectiveness of three different short-course antibiotic regimens and single-dose fosfomycin for uncomplicated lower urinary tract infections in women (SCOUT): a pragmatic, multicentre, open-label, randomised clinical trial. Lancet. 2026 Apr 25;407(10539):1603-1613. doi: 10.1016/S0140-6736(25)02171-3. Epub 2026 Apr 20.
- Garcia-Sangenis A, Morros R, Aguilar-Sanchez M, Medina-Perucha L, Leiva A, Ripoll J, Martinez-Pecharroman M, Bartolome-Moreno CB, Magallon Botaya R, Marin-Canada J, Molero JM, Moragas A, Troncoso A, Monfa R, Llor C; SCOUT Study Group. 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 (SCOUT study): study protocol for a randomised clinical trial. BMJ Open. 2021 Nov 25;11(11):e055898. doi: 10.1136/bmjopen-2021-055898.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Fosfomycin | Small molecule | 3 g | Oral |
| Comparator | Nitrofurantoin | Unknown | 100 mg | Oral |
| Comparator | Pivmecillinam | Small molecule | 400 mg | Oral |