BMJ Open (Nov 2021)

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

  • Alfonso Leiva,
  • Joana Ripoll,
  • Bonaventura Bolibar,
  • Anna Berenguera,
  • Ana Moragas,
  • Ana García-Sangenís,
  • Rosa Morros,
  • Ramon Monfà,
  • Carl Llor,
  • Laura Medina-Perucha,
  • Rosa Magallón Botaya,
  • José M Molero,
  • Mercedes Aguilar-Sánchez,
  • Mar Martínez-Pecharromán,
  • Cruz B Bartolomé-Moreno,
  • Jaime Marín-Cañada,
  • Amelia Troncoso,
  • Dan Ouchi-Vernet,
  • Josep M. Cots,
  • Sílvia Cobo,
  • Fede Gómez,
  • Ignacio Ricci Cabello,
  • Catalina Vicens-Caldentey,
  • José I. Ramírez-Manent,
  • Aina Soler-Mieras,
  • Lourdes Quintana-Torres,
  • Joan Llobera-Cànaves,
  • Antonia Roca-Casas,
  • Aina M. Yáñez-Juan,
  • Eva Alcoceba-Cruixent,
  • Antonio Ballester-Camps,
  • Oana Bulilete,
  • M. Consuelo Camionero-Soto,
  • Joan Pou Bordoy,
  • M. Antonia Sánchez-Calavera,
  • Pilar Royán-Molero,
  • Nima Peyman-Fard Shafi-Tabatebaei,
  • África García-Roy,
  • Raquel Jabal-Calvillo,
  • Lucía Lasilla-Fernández,
  • Andrea Hurtado-Gutiérrez,
  • Pilar Vich-Pérez,
  • Rocío C Triano-Sánchez,
  • José Ávila-Sánchez,
  • Manuel Gómez-García,
  • Isabel Prieto-Checa,
  • Mar Nogueol-Álvarez,
  • Cristina Sánchez-Iñigo,
  • Maria Victoria Garcia Espinosa,
  • Marta Lor Leandro,
  • Lidia Escribano González,
  • Luís Benito Ortiz

DOI
https://doi.org/10.1136/bmjopen-2021-055898
Journal volume & issue
Vol. 11, no. 11

Abstract

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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 (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.Trial registration number NCT04959331; EudraCT Number: 2021-001332-26.Time schedule January 2022 to April 2023.