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

Ana Garcia-Sangenís, Rosa Morros, Mercedes Aguilar-Sánchez, Laura Medina-Perucha, Alfonso Leiva, Joana Ripoll, Mar Martínez-Pecharromán, Cruz B Bartolomé-Moreno, Rosa Magallon Botaya, Jaime Marín-Cañada, José M Molero, Ana Moragas, Amelia Troncoso, Ramon Monfà, Carl Llor, SCOUT Study Group, Bonaventura Bolíbar, Dan Ouchi-Vernet, Anna Berenguera, 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, Ana Garcia-Sangenís, Rosa Morros, Mercedes Aguilar-Sánchez, Laura Medina-Perucha, Alfonso Leiva, Joana Ripoll, Mar Martínez-Pecharromán, Cruz B Bartolomé-Moreno, Rosa Magallon Botaya, Jaime Marín-Cañada, José M Molero, Ana Moragas, Amelia Troncoso, Ramon Monfà, Carl Llor, SCOUT Study Group, Bonaventura Bolíbar, Dan Ouchi-Vernet, Anna Berenguera, 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

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.

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.

Keywords: microbiology; primary care; public health; urinary tract infections.

Conflict of interest statement

Competing interests: CL reports receiving research grants from Abbott Diagnostics. The other authors have nothing to declare.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

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