000110652 001__ 110652 000110652 005__ 20230519145520.0 000110652 0247_ $$2doi$$a10.1136/bmjopen-2021-055898 000110652 0248_ $$2sideral$$a126809 000110652 037__ $$aART-2021-126809 000110652 041__ $$aeng 000110652 100__ $$aGarcia-Sangenís, A. 000110652 245__ $$aClinical 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 000110652 260__ $$c2021 000110652 5060_ $$aAccess copy available to the general public$$fUnrestricted 000110652 5203_ $$aIntroduction 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. Ethics and dissemination The study was approved by the Ethical Board of IDIAP Jordi Gol (referencenumber: 21/173-AC) and Spanish Agency of Medicines and Medical Devices. The findings of this trial will be disseminated through research conferences and peer-review journals. © 2021 BMJ Publishing Group. All rights reserved. 000110652 536__ $$9info:eu-repo/grantAgreement/ES/ISCIII-RedIAPP/RD16-0007-0005 000110652 540__ $$9info:eu-repo/semantics/openAccess$$aby-nc$$uhttp://creativecommons.org/licenses/by-nc/3.0/es/ 000110652 590__ $$a3.007$$b2021 000110652 592__ $$a0.982$$b2021 000110652 594__ $$a3.9$$b2021 000110652 591__ $$aMEDICINE, GENERAL & INTERNAL$$b86 / 172 = 0.5$$c2021$$dQ2$$eT2 000110652 593__ $$aMedicine (miscellaneous)$$c2021$$dQ1 000110652 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/publishedVersion 000110652 700__ $$aMorros, R. 000110652 700__ $$aAguilar-Sánchez, M. 000110652 700__ $$aMedina-Perucha, L. 000110652 700__ $$aLeiva, A. 000110652 700__ $$aRipoll, J. 000110652 700__ $$aMartínez-Pecharromán, M. 000110652 700__ $$0(orcid)0000-0001-8820-9105$$aBartolomé-Moreno, C.B.$$uUniversidad de Zaragoza 000110652 700__ $$0(orcid)0000-0002-5494-6550$$aMagallón Botaya, R.$$uUniversidad de Zaragoza 000110652 700__ $$aMarín-Cañada, J. 000110652 700__ $$aMolero, J.M. 000110652 700__ $$aMoragas, A. 000110652 700__ $$aTroncoso, A. 000110652 700__ $$aMonfà, R. 000110652 700__ $$aLlor, C. 000110652 7102_ $$11007$$2610$$aUniversidad de Zaragoza$$bDpto. Medicina, Psiqu. y Derm.$$cArea Medicina 000110652 773__ $$g11, 11 (2021), e055898 [8 pp]$$pBMJ Open$$tBMJ Open$$x2044-6055 000110652 8564_ $$s596185$$uhttps://zaguan.unizar.es/record/110652/files/texto_completo.pdf$$yVersión publicada 000110652 8564_ $$s3119078$$uhttps://zaguan.unizar.es/record/110652/files/texto_completo.jpg?subformat=icon$$xicon$$yVersión publicada 000110652 909CO $$ooai:zaguan.unizar.es:110652$$particulos$$pdriver 000110652 951__ $$a2023-05-18-15:22:34 000110652 980__ $$aARTICLE