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
Garcia-Sangenís, A. ; Morros, R. ; Aguilar-Sánchez, M. ; Medina-Perucha, L. ; Leiva, A. ; Ripoll, J. ; Martínez-Pecharromán, M. ; Bartolomé-Moreno, C.B. (Universidad de Zaragoza) ; Magallón Botaya, R. (Universidad de Zaragoza) ; Marín-Cañada, J. ; Molero, J.M. ; Moragas, A. ; Troncoso, A. ; Monfà, R. ; Llor, C.
Resumen: Introduction 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.
Idioma: Inglés
DOI: 10.1136/bmjopen-2021-055898
Año: 2021
Publicado en: BMJ Open 11, 11 (2021), e055898 [8 pp]
ISSN: 2044-6055
Factor impacto JCR: 3.007 (2021)
Categ. JCR: MEDICINE, GENERAL & INTERNAL rank: 86 / 172 = 0.5 (2021) - Q2 - T2
Factor impacto CITESCORE: 3.9 - Medicine (Q2)
Factor impacto SCIMAGO: 0.982 - Medicine (miscellaneous) (Q1)
Financiación: info:eu-repo/grantAgreement/ES/ISCIII-RedIAPP/RD16-0007-0005
Tipo y forma: Article (Published version)
Área (Departamento): Area Medicina (Dpto. Medicina, Psiqu. y Derm.)
You must give appropriate credit, provide a link to the license, and indicate if changes were made. You may do so in any reasonable manner, but not in any way that suggests the licensor endorses you or your use. You may not use the material for commercial purposes.
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Idioma: Inglés
DOI: 10.1136/bmjopen-2021-055898
Año: 2021
Publicado en: BMJ Open 11, 11 (2021), e055898 [8 pp]
ISSN: 2044-6055
Factor impacto JCR: 3.007 (2021)
Categ. JCR: MEDICINE, GENERAL & INTERNAL rank: 86 / 172 = 0.5 (2021) - Q2 - T2
Factor impacto CITESCORE: 3.9 - Medicine (Q2)
Factor impacto SCIMAGO: 0.982 - Medicine (miscellaneous) (Q1)
Financiación: info:eu-repo/grantAgreement/ES/ISCIII-RedIAPP/RD16-0007-0005
Tipo y forma: Article (Published version)
Área (Departamento): Area Medicina (Dpto. Medicina, Psiqu. y Derm.)
You must give appropriate credit, provide a link to the license, and indicate if changes were made. You may do so in any reasonable manner, but not in any way that suggests the licensor endorses you or your use. You may not use the material for commercial purposes. Exportado de SIDERAL (2023-05-18-15:22:34)
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Record created 2022-02-15, last modified 2023-05-19