Tailoring antibiotic duration for respiratory tract infections in primary care: protocol for a pragmatic randomized controlled trial study (STORM)

Abstract

Background: Combating the rise of drug-resistant organisms and minimizing side effects requires a shift in how we approach the duration of antibiotic therapy. A promising strategy involves tailoring the length of antibiotic therapy to patients' needs, Objective: This study aims to assess whether shortening antibiotic therapy based on patients' recovery time is as effective as completing the full course in treating acute respiratory tract infections (RTIs). Methods: We plan to enroll a minimum of 474 outpatients ranging from 18 to 75 years of age with clinical features of acute RTIs across Spanish health centers. Patients diagnosed with acute lower RTIs or acute rhinosinusitis, deemed by clinicians to require a beta-lactam course, will be randomized to either usual care, involving a full-course antibiotic therapy based on current guidelines, or a tailored approach. In the intervention group, patients will be advised to visit the center as soon as they feel better and are afebrile for a clinical assessment and C-reactive protein rapid testing. Treatment will be discontinued if these clinical results are normal. The primary outcome will be assessment of clinical resolution at day 14, while secondary outcomes include antibiotics given and duration; adherence to the prescribed antibiotic; other therapies given; early clinical assessment at day 7; days of severe, moderate, and any symptom, complications and reattendance within the first month; drug-related adverse events; absenteeism; and health-related quality of life. All participants will be given a symptom diary, recording their symptoms each evening. Additionally, a cost-effectiveness study and qualitative studies involving clinicians and patients aimed at exploring the strategy's pros, cons, uptake, and satisfaction levels will be carried out. Conclusions: We will examine whether adults who present with symptoms of RTI who are treated with antibiotic courses until they feel better are as effective as longer standard courses. It is highly important that a possible reduction in the antibiotic course as soon as the patient feels better does not compromise patients' recovery. This comprehensive approach aims to shed light on Trial Registration: ClinicalTrials.gov NCT06581367; https://clinicaltrials.gov/study/NCT06581367