The STOP-AB trial protocol: efficacy and safety of discontinuing patient antibiotic treatment when physicians no longer consider it necessary

• Published in: BMJ open Vol. 7; no. 5; p. e015814
• Main Authors: Llor, Carl, Moragas, Ana, Bayona, Carolina, Cots, Josep M, Molero, José M, Ribas, Joana, Fóthy, Julio Francisco, Gutiérrez, Isabel, Sánchez, Coro, Ortega, Jesús, Arranz, Javier, Botanes, Jenifer, Robles, Purificación
• Format: Journal Article
• Language: English
• Published: England BMJ Publishing Group LTD 06.06.2017; BMJ Publishing Group
• Subjects: Administració de medicaments; Administration of drugs; Adolescent; Adult; Aged; Anti-Bacterial Agents - administration & dosage; Anti-Bacterial Agents - adverse effects; Antibiotics; Antibiòtics; Antimicrobial agents; Assaigs clínics; Bacterial infections; Bronchitis; Clinical medicine; Clinical trials; Drug Administration Schedule; Drug resistance; Family physicians; Female; General practice / Family practice; Humans; Infections; Infectious diseases; Linear Models; Male; Middle Aged; Patient satisfaction; Patient Satisfaction - statistics & numerical data; Patients; Perceptions; Pneumonia; Primary care; Primary Health Care - statistics & numerical data; Public health; Research Design; Respiratory Tract Infections - drug therapy; Respiratory Tract Infections - microbiology; Salut pública; Severity of Illness Index; Spain; Treatment Outcome; Viral infections; Virus Diseases - complications; Young Adult; United States > US; Europe; Spain; Clinical trials; Public health; PRIMARY CARE; Respiratory infections
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2016-015814

IntroductionSince 2011, the Spanish Society of Family Medicine has recommended general practitioners (GPs) to ask their patients to stop taking antibiotics when they suspect a viral infection. However, this practice is seldom used because uncertainty about diagnosis, and fear of consequences of discontinuing antibiotic therapy, as well as perceived pressure to continue prescribing antibiotics and potential conflict with patients are more of a concern for GPs than antibiotic resistance. The main objective of this study is to determine whether discontinuation of antibiotic therapy when a GP no longer considers it necessary has any impact on the number of days with severe symptoms.Methods and analysisThis is a multicentre, open-label, randomised controlled clinical trial. The study was conducted in 10 primary care centres in Spain. We included patients from 18 to 75 years of age with uncomplicated acute respiratory tract infections—acute rhinosinusitis, acute sore throat, influenza or acute bronchitis—who had previously taken any dose of antibiotic for <3 days, which physicians no longer considered necessary. The patients were randomly assigned to the usual strategy of continuing antibiotic treatment or to discontinuing antibiotic therapy. A sample size of 240 patients per group was calculated on the basis of a reduction of 1 day in the duration of severe symptoms being a clinically relevant outcome. The primary outcome was the duration of severe symptoms, that is, symptoms scored 5 or 6 by means of validated symptom diaries. Secondary outcomes included antibiotics taken, adverse events, patient satisfaction and complications within the first 3 months.Ethics and disseminationThe study was approved by the Ethical Board of Fundació Jordi Gol i Gurina (reference number: 16/093). The findings of this trial will bedisseminated through research conferences and peer-reviewed journals.Trial registration numberNCT02900820; pre-results.