Garcia Sangenís, AnaMorros Pedrós, RosaAguilar Sánchez, MercedesMedina Perucha, LauraLeiva, AlfonsoRipoll, JoanaMartínez Pecharromán, MarBartolomé Moreno, Cruz BMagallón Botaya, RosaMarín Cañada, JaimeMolero, José M.Moragas, AnaTroncoso, AmeliaMonfà, RamonLlor, Carl2021-12-132021-12-132021-11-012044-6055https://hdl.handle.net/2445/181799Introduction: Uncomplicated lower urinary tract infections (uLUTI) are a common problem in primary care. Current local guidelines recommend the use of a single 3 g dose of fosfomycin. However, most general practitioners (GP) prefer short-course therapies to single-dose therapy. No study has compared head-to-head short-course antimicrobial agents for uLUTIs. Therefore, the aim of this randomised clinical trial is to compare three different short-course antibiotic therapies with a single-dose of fosfomycin for these infections. Methods and analysis: This will be a pragmatic, multicentre, parallel group, open trial. Women aged 18 or older and with symptoms of uLUTI and a positive urine dipstick analysis will be randomised to one of the following four groups: a single dose of 3 g of fosfomycin, 2 days of 3 g of fosfomycin o.d., 3 days of pivmecillinam 400 mg three times per day (t.i.d) or 5 days of nitrofurantoin 100 mg t.i.d. A total sample of 1120 patients was calculated. The primary endpoint is clinical effectiveness at day 7, defined as cure of symptoms reported by the patients in a diary including four symptoms: dysuria, urgency, frequency and suprapubic pain, which will be scored on a 4-point severity scale (not present/mild/moderate/severe). 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. If positive, antibiograms for the three antibiotics studied will be performed. Bacterial eradication will be measured at days 14 and 28.8 p.application/pdfengcc by-nc (c) Garcia Sangenís, Ana et al, 2021http://creativecommons.org/licenses/by-nc/3.0/es/Infeccions del tracte urinariTerapèuticaAntibiòticsUrinary tract infectionsTherapeuticsAntibioticsinfo:eu-repo/semantics/article2021-12-10info:eu-repo/semantics/openAccess34824124