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Title: | 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 |
Author: | Garcia Sangenís, Ana Morros Pedrós, Rosa Aguilar Sánchez, Mercedes Medina Perucha, Laura Leiva, Alfonso Ripoll, Joana Martínez Pecharromán, Mar Bartolomé Moreno, Cruz B Magallon Botaya, Rosa Marín Cañada, Jaime Molero, José M. Moragas, Ana Troncoso, Amelia Monfà, Ramon Llor, Carl |
Keywords: | Infeccions del tracte urinari Terapèutica Antibiòtics Urinary tract infections Therapeutics Antibiotics |
Issue Date: | 1-Nov-2021 |
Publisher: | BMJ |
Abstract: | 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. |
Note: | Reproducció del document publicat a: https://doi.org/10.1136/bmjopen-2021-055898 |
It is part of: | BMJ Open, 2021, vol. 11, num. 11 |
URI: | http://hdl.handle.net/2445/181799 |
Related resource: | https://doi.org/10.1136/bmjopen-2021-055898 |
ISSN: | 2044-6055 |
Appears in Collections: | Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) |
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