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

Media type: E-Article
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
Contributor: Garcia-Sangenís, Ana; Morros, 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
Published: BMJ, 2021
Published in: BMJ Open, 11 (2021) 11, Seite e055898
Language: English
DOI: 10.1136/bmjopen-2021-055898
ISSN: 2044-6055
Keywords: General Medicine
Origination:
Footnote:
Description: <jats:sec><jats:title>Introduction</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Methods and analysis</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Ethics and dissemination</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Trial registration number</jats:title><jats:p><jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="clintrialgov" xlink:href="NCT04959331">NCT04959331</jats:ext-link>; EudraCT Number: 2021-001332-26.</jats:p></jats:sec><jats:sec><jats:title>Time schedule</jats:title><jats:p>January 2022 to April 2023.</jats:p></jats:sec>
Access State: Open Access

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