{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,26]],"date-time":"2026-08-26T20:34:27Z","timestamp":1787776467557,"version":"build-2784847793"},"reference-count":37,"publisher":"BMJ","issue":"11","license":[{"start":{"date-parts":[[2021,11,24]],"date-time":"2021-11-24T00:00:00Z","timestamp":1637712000000},"content-version":"unspecified","delay-in-days":23,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Carlos III Institute of Health (ISCIII), Ministry of Science and Innovation","award":["Academic Clinical Trials Call, reference ICI20\/001"],"award-info":[{"award-number":["Academic Clinical Trials Call, reference ICI20\/001"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2021,11,1]]},"published-print":{"date-parts":[[2021,11]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <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\u2009g 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>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <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\u2009g of fosfomycin, 2\u2009days of 3\u2009g of fosfomycin o.d., 3\u2009days of pivmecillinam 400\u2009mg three times per day (t.i.d) or 5\u2009days of nitrofurantoin 100\u2009mg 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>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <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>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT04959331\">NCT04959331<\/jats:ext-link>\n                      ; EudraCT Number: 2021-001332-26.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Time schedule<\/jats:title>\n                    <jats:p>January 2022 to April 2023.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2021-055898","type":"journal-article","created":{"date-parts":[[2021,11,25]],"date-time":"2021-11-25T11:39:39Z","timestamp":1637840379000},"page":"e055898","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":8,"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"],"prefix":"10.1136","volume":"11","clinical-trial-number":[{"clinical-trial-number":"nct04959331","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6689-6466","authenticated-orcid":false,"given":"Ana","family":"Garcia-Sangen\u00eds","sequence":"first","affiliation":[{"name":"Institut de Recerca en Atencio Primaria Jordi Gol, Barcelona, Catalonia, Spain"},{"name":"UICEC de IDIAP Jordi Gol-Plataforma ScREN, Barcelona, Catalonia, Spain"},{"name":"Medicines Research Unit, Institut de Recerca en Atencio Primaria Jordi Gol, Barcelona, Catalonia, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6752-8748","authenticated-orcid":false,"given":"Rosa","family":"Morros","sequence":"additional","affiliation":[{"name":"Medicines Research Unit, Institut de Recerca en Atencio Primaria Jordi Gol, Barcelona, Catalonia, Spain"},{"name":"Departament de Farmacologia i Terap\u00e8utica, Universitat Aut\u00f2noma de Barcelona, Bellaterra, Cerdanyola del Vall\u00e8s, Catalonia, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mercedes","family":"Aguilar-S\u00e1nchez","sequence":"additional","affiliation":[{"name":"Microbiology Department, Hospital Universitari de Bellvitge, L\"Hospitalet de Llobregat, Catalonia, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2981-2614","authenticated-orcid":false,"given":"Laura","family":"Medina-Perucha","sequence":"additional","affiliation":[{"name":"Institut de Recerca en Atencio Primaria Jordi Gol, Barcelona, Catalonia, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5306-8533","authenticated-orcid":false,"given":"Alfonso","family":"Leiva","sequence":"additional","affiliation":[{"name":"Primary Care Research Unit of Mallorca, Balearic Islands Health Services; 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