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
García-Sangenís, Ana (Institut Universitari d'Investigació en Atenció Primària Jordi Gol)
Morros, Rosa (Universitat Autònoma de Barcelona. Departament de Farmacologia, de Terapèutica i de Toxicologia)
Aguilar-Sánchez, Mercedes (Hospital Universitari de Bellvitge)
Medina-Perucha, Laura (Institut de Recerca en Atencio Primaria Jordi Gol)
Leiva, Alfonso (Servei de Salut de les Illes Balears)
Ripoll, Joana (Servei de Salut de les Illes Balears)
Martínez-Pecharromán, Mar (Instituto de Investigación Sanitaria de Aragón)
Bartolomé-Moreno, Cruz B. (Universidad de Zaragoza)
Magallon Botaya, Rosa (Universidad de Zaragoza)
Marín-Cañada, Jaime (Centro de Salud Villarejo de Salvanés)
Molero, José M. (Comunidad de Madrid Servicio Madrileno de Salud)
Moragas, Ana (Universitat Rovira i Virgili)
Troncoso, Amelia (Institut Català de la Salut)
Monfà, Ramon (Institut de Recerca en Atencio Primaria Jordi Gol)
Llor, Carl (University of Southern Denmark)

Data:	2021
Resum:	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. 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. The study was approved by the Ethical Board of IDIAP Jordi Gol (reference number: 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. ; EudraCT Number: 2021-001332-26. January 2022 to April 2023.
Ajuts:	Instituto de Salud Carlos III ICI20/00100 Ministerio de Economía y Competitividad RD16/0007/0001 Ministerio de Economía y Competitividad RD16/0007/0005 Ministerio de Economía y Competitividad RD16/0007/0008 Ministerio de Economía y Competitividad RD16/0007/0013
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Urinary tract infections ; Public health ; Microbiology ; Primary care
Publicat a:	BMJ open, Vol. 11 (november 2021) , ISSN 2044-6055

DOI: 10.1136/bmjopen-2021-055898
PMID: 34824124

8 p, 575.0 KB

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