Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-01-19 @ 5:02 PM
Study NCT ID:
NCT06581367
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-09-03
First Post:
2024-08-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tailoring Antibiotic Duration for Respiratory Tract Infections in Primary Care
Sponsor:
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Organization:
Study Overview
Official Title:
Tailoring Antibiotic Duration for Respiratory Tract Infections in Primary Care: a Pragmatic Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STORM
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.
Detailed Description:
Background. Combating the rise of drug-resistant organisms and minimizing the side effects demand a shift in how we approach antibiotic therapy duration. A study focused on tailoring antibiotic length of therapy to patients\' needs as soon as they feel better, is a promising strategy. The investigators aim to assess whether adjusting the duration of antibiotic therapy according to individual patient needs, shortening it to the time when the patient feels better, proves as effective as completing the antibiotic course in acute respiratory tract infections (RTIs).
Methods. The investigators plan to enroll a minimum of 474 outpatients ranging from 18 to 75 years of age with clinical features of acute RTIs across 25 Spanish primary healthcare 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 after completing two full days of antibiotic. Treatment will be discontinued if these clinical results are normal. The primary outcome will be overall clinical efficacy at day 14, while secondary outcomes include duration, doses of antibiotic taken, complications and reattendance within the first month, drug-related adverse events, antibiotic given, other therapies, days of severe and moderate symptoms, days of symptoms, 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.
Discussion. The investigators will examine whether adults who present with symptoms of acute lower RTI or rhinosinusitis in general practice, 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 or clinical course, which we will assess closely. This comprehensive approach aims to shed light on the practicality and impact of tailoring antibiotic duration in RTIs.
Methods. The investigators plan to enroll a minimum of 474 outpatients ranging from 18 to 75 years of age with clinical features of acute RTIs across 25 Spanish primary healthcare 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 after completing two full days of antibiotic. Treatment will be discontinued if these clinical results are normal. The primary outcome will be overall clinical efficacy at day 14, while secondary outcomes include duration, doses of antibiotic taken, complications and reattendance within the first month, drug-related adverse events, antibiotic given, other therapies, days of severe and moderate symptoms, days of symptoms, 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.
Discussion. The investigators will examine whether adults who present with symptoms of acute lower RTI or rhinosinusitis in general practice, 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 or clinical course, which we will assess closely. This comprehensive approach aims to shed light on the practicality and impact of tailoring antibiotic duration in RTIs.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: