Tailoring Antibiotic Duration for Respiratory Tract Infections in Primary Care

NCT06581367 | Not Yet Recruiting Phase 4

• 1 other identifier: IJG-STORM-2024
• Study Type: interventional
• Target: 474
• Locations: 0 countries
• Sites: N/A

Brief Summary

The rise of drug-resistant organisms and the need to minimize side effects calls for a new approach to antibiotic therapy duration. This study explores tailoring the length of antibiotic treatment to patient recovery, focusing on whether adjusting therapy based on when the patient feels better is as effective as completing the prescribed course for acute respiratory tract infections (RTIs). The investigators will enroll 474 outpatients aged 18-75 with acute RTIs across 25 Spanish healthcare centers. Patients will be randomized into two groups: one following standard full-course antibiotic therapy, and another receiving a tailored approach, where treatment may be shortened based on clinical assessments. The primary outcome is clinical efficacy at day 14. Secondary outcomes include antibiotic duration, complications, and quality of life.

Conditions

Acute Respiratory Tract Infection

Keywords

Antibacterial Agents Antimicrobial Resistance; Duration; Primary Health Care; Personalized Medicine; Drugs, Customized; Drug Resistance, Microbial; Patient-Centered Care

Outcome Measures

Primary Outcomes (1)

• Clinical resolution

  Number of patients with disappearance of fever, disappearance or improvement in overall condition (all scores \<2), such that no additional antimicrobial treatment is necessary.

  Day 14

Secondary Outcomes (11)

• Duration of antibiotic therapy

  Day 14

• Doses taken

  Day 14

• Duration of severe symptoms

  Day 14

• Duration of moderate symptoms

  Day 14

• Total resolution of symptoms

  Day 14

Study Arms (2)

Control group

PLACEBO COMPARATOR

Full-course antibiotic therapy based on current guidelines (7 days).

Drug: Complete a 7-day course

Intervention group

ACTIVE COMPARATOR

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 after completing two full days of antibiotic.

Drug: Tailoring the course duration to the patient's needs.

Interventions

Tailoring the course duration to the patient's needs. DRUG

Patients will be advised to visit the center as soon as they feel better and are afebrile for a clinical assessment including vital signs (temperature, blood pressure, respiratory rate, pulse, and oxygen saturation) and C-reactive protein rapid testing after completing two full days of antibiotic.

Also known as: Patient-centered approach

Intervention group

Complete a 7-day course DRUG

The antibiotic course must be completed (7 days at least).

Also known as: Completion of the antibiotic course

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Either adults with a) acute cough (new cough or worsening of a previous cough) as the predominant symptom which the clinician believes to be a bacterial acute lower RTI, such as community-acquired pneumonia, acute bronchitis or acute chronic obstructive pulmonary disease (COPD) exacerbations, or b) an acute bacterial rhinosinusitis
• Doctors deem beta-lactam therapy (given every eight hours for a minimum of seven days) is necessary

You may not qualify if:

• RTIs different from a lower RTI or acute rhinosinusitis
• Patients with suspected septicemia (quick Quick Sequential Organ Failure Assessment: respiratory rate ≥22 breaths/minute, systolic blood pressure \<100 mm Hg or altered mental status with a Glasgow score \< 5) ≥2
• Patients with pneumonia and \[Confusion, respiratory rate ≥30 breaths/minute, blood pressure \< 90/60 mm Hg, or age \>65 yr.\] ≥1
• Patients with very severe COPD (Forced Expiratory Volume in One Second \<30%)
• Patients with COPD who have taken four or more antibiotic courses in the previous year, presence of significant bronchiectasis, and/or isolation of Pseudomonas in a previous sputum culture
• Patients with reported allergy to beta-lactams
• Patients who have taken an antibiotic in the previous two weeks
• Patients who have been hospitalized in the last two weeks
• A working diagnosis of a non-infective disorder, such as heart failure, pulmonary embolus, esophageal reflux
• Immunocompromised patients, such as HIV infection, patients taking immunosuppressive treatment, antineoplastic therapy, or systemic corticosteroids
• Currently participating in another clinical trial
• Previously participated in the STORM study
• Active neoplasia
• Terminal illness
• Institutionalized patient

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead

Related Publications (2)

• Llor C, Frimodt-Moller N, Miravitlles M, Kahlmeter G, Bjerrum L. Optimising antibiotic exposure by customising the duration of treatment for respiratory tract infections based on patient needs in primary care. EClinicalMedicine. 2024 Jul 3;74:102723. doi: 10.1016/j.eclinm.2024.102723. eCollection 2024 Aug.

  PMID: 39070175 BACKGROUND

• Morros R, Moragas A, Garcia-Sangenis A, Monfa R, Miravitlles M, Vallejo-Torres L, Jarca CI, Llor C. Tailoring Antibiotic Duration for Respiratory Tract Infections in Primary Care: Protocol for a Pragmatic Randomized Controlled Trial Study (STORM). JMIR Res Protoc. 2025 Oct 20;14:e75453. doi: 10.2196/75453.

  PMID: 41115271 DERIVED

Study Officials

• Rosa Morros, PhD

  University Institute in Primary Care Research Jordi Gol, Barcelona

  STUDY CHAIR

Central Study Contacts

Ramon Monfà, MSc

CONTACT

0034685409860; rmonfa@idiapjgol.org

Ana García-Sangenís, MSc

CONTACT

0034638687717; agarcia@idiapjgol.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients with acute RTIs will be randomized to either usual care (full-course antibiotic therapy based on current guidelines), or a tailored approach (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 after completing two full days of antibiotic).

Study Record Dates

• First Submitted: August 28, 2024
• First Posted: September 3, 2024
• Study Start: October 1, 2025
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: September 3, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 2025 until 2027
• Access Criteria: All the investigators who want to have this information shared under request.