Tailoring Antibiotic Duration for Respiratory Tract Infections in Primary Care - Protocol for a Pragmatic Randomized Controlled Trial Study (STORM)

Sep 30, 2026

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Background: Combating rising drug resistance and minimizing side effects require changing how antibiotic duration is determined, including stopping therapy when patients feel better. Objective: Assess whether shortening antibiotic treatment based on patients’ recovery time is as effective as completing the full course for acute respiratory tract infections. Methods: A pragmatic randomized trial will enroll at least 474 outpatients with acute RTIs across Spanish health centers, comparing usual guideline-based full-course therapy versus a tailored discontinuation strategy guided by symptoms and rapid C-reactive protein testing. Key outcomes include clinical resolution at day 14 and antibiotic exposure, adherence, and safety measures.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages17

Reading Time43 min

AccessFree to download

Abstract

Background

Objective

Methods

Results

Conclusions

Trial Registration

Introduction

Antibiotic use and antimicrobial resistance

JMIR RESEARCH PROTOCOLS Morros et al Protocol Tailoring Antibiotic Duration for Respiratory Tract Infections in Primary Care: Protocol for a Pragmatic Randomized Controlled Trial Study (STORM) | Rosa Morros 1,2,3*, PhD; Ana Moragas 1,2,4*, PhD; Ana García-Sangenís 1,2*, MSc; Ramon Monfà1,3*, MSc; Marc Miravitlles5*, PhD; Laura Vallejo-Torres6*, PhD; Carmen I Jarca7*, MD; Carl Llor1,2,8*, PhD | | --- | | 1Institut Universitari d'Investigació en Atenció Primària Jordi Gol, Barcelona, Spain 2Instituto de Salud Carlos III, CIBER de Enfermedades Infecciosas, Madrid, Spain 3Universitat Autònoma de Barcelona, Bellaterra, Spain
4Jaume I Health Centre, University Rovira i Virgili, Tarragona, Spain 5Pneumology Department, Vall d'Hebron Hospital Universitari, Barcelona, Spain
6Department of Quantitative Methods in Economics and Management, Universidad de Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain 7OSI Tolosaldea, Osakidetza, Andoain Health Center, Andoain, Spain
8Department of Public Health, University of Southern Denmark, Odense, Denmark
*all authors contributed equally
Corresponding Author:
Carl Llor, PhD
Institut Universitari d'Investigació en Atenció Primària Jordi Gol Gran Via de les Corts Catalanes, 587, àtic
Barcelona, 08007 Spain
Phone: 1 34 0644673590
Email: [carles.llor@gmail.com](carles.llor@gmail.com)
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, allowing discontinuation once patients feel better. 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 β-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. Results: The final results will be published by the end of 2027. 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 the practicality and impact of tailoring antibiotic duration in RTIs. Trial Registration: ClinicalTrials.gov NCT06581367; [https://clinicaltrials.gov/study/NCT06581367](https://clinicaltrials.gov/study/NCT06581367) [https://www.researchprotocols.org/2025/1/e75453](htt

FAQs

What is the main goal of the STORM trial protocol?

To test whether shortening antibiotic therapy based on patients’ recovery time is as effective as completing the full recommended course for acute respiratory tract infections.

How will participants be assigned to study groups?

Patients with acute lower respiratory tract infections or acute rhinosinusitis, for which clinicians judge a β-lactam course is needed, will be randomized to usual care (full-course antibiotics per guidelines) or a tailored approach.

When will antibiotic treatment be discontinued in the tailored approach?

Patients will be advised to return as soon as they feel better and are afebrile for clinical assessment and rapid C-reactive protein testing; treatment will be discontinued if clinical results are normal.

Sep 30, 2026

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