Adapting the length of antibiotics for respiratory tract infections in primary care.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Institut Universitari D Investigacio En Atencion Primaria Jordi Gol

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

12 Nov 2025 → ongoing

Decision date (initial)

2025-08-12

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Institute of Health Carlos III (ISCIII)

External identifiers

EU CT number

2024-518683-13-00

ClinicalTrials.gov

NCT06581367

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To assess the overall assessment of the clinical efficacy at day 14

Secondary objectives 13

1. Adherence to the prescribed antibiotic therapy
2. Duration of antibiotic therapy, in days
3. First day the patient feels better
4. Utilization of antibiotics others than the study medication and other symptomatic therapies
5. Duration of severe symptoms
6. Duration of moderate symptoms
7. Total resolution of symptoms
8. Number of re-attendances to any doctor for new or worsening symptoms
9. Number of complications related to the Respiratory Tract Infection
10. Number of days of work absenteeism
11. Change in health-related quality of life
12. Drug-associated adverse events related to the antibiotic
13. Early clinical assessment at day 7 in both groups, based on the score given in the self-registered RTI symptom diaries*. Study point: day 14 (when patients return diaries).

Conditions and MedDRA coding

Acute lower Respiratory Tract Infection or acute rhinosinusitis

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Age ranging from 18 to 75 years of age
2. Acute lower Respiratory Tract Infection or acute bacterial rhinosinusitis
3. GPs deem a beta-lactam therapy for at least seven days is necessary

Exclusion criteria 16

1. Respiratory Tract Infections different from a lower RTI or acute rhinosinusitis
2. The doctor decides not to give an antibiotic for this RTI
3. Patients with suspected septicaemia, based on the Quick SOFA scale; patients with two or more of the following criteria must be excluded: a) respiratory rate ≥22 breaths/minute; b) systolic blood pressure <100 mm Hg, and/or c) altered mental status with a Glasgow score <15)
4. Patients with a severe community-acquired pneumonia, based on the CRB65 scale: patients with any of the following criterion must be excluded: a) confusion; b) respiratory rate ≥30 breaths/minute; c) systolic blood pressure <90 mm Hg or diastolic ≤60 mm Hg; and/or d) age ≥65 years
5. 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
6. Patients with reported allergy to beta-lactams
7. Patients who have taken an antibiotic in the previous two weeks
8. A working diagnosis of a non-infective disorder, such as heart failure, pulmonary embolus, oesophageal reflux
9. Immunocompromised patients, such as HIV infection, patients taking immunosuppressive treatment, antineoplastic therapy, or systemic corticosteroids
10. Inability/unable to understand and/or take part in the clinical trial
11. Currently participating in another clinical trial
12. Previously participated in the STORM study
13. Active neoplasia
14. Terminal illness
15. Institutionalized patient
16. Inability to understand and/or participate in the clinical trial

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Clinical resolution is defined as disappearance of fever, disappearance or improvement in overall condition, such that no additional antimicrobial treatment is necessary. Any other clinical outcome that does not meet the definition is considered treatment failure

Secondary endpoints 13

1. Concordance of the antibiotic doses taken with the recommended guidelines, as recorded in the questionnaire and self-registered RTI symptom diaries
2. Number of patients discontinuing treatment in both groups and what day they discontinue recorded in the self-registered RTI symptom diaries and eCAP
3. First day the patient feels better, as recorded in the questionnaire and self-registered RTI symptom diaries
4. Antibiotics others than the study medication and other symptomatic therapies within the first two weeks recorded in the self-registered RTI symptom diaries
5. Number of days until the last day the patient scores 5 in any of the symptoms recorded in the self-registered RTI symptom diaries
6. Number of days until the last day the patient scores 3 in any of the symptoms recorded in the self-registered RTI symptom diaries
7. Number of days until the last day the patient scores 0 in all the symptoms recorded in the self-registered RTI symptom diaries
8. Number of re-attendances to any doctor for new or worsening symptoms regarding the RTI regarding the infection, within 28 days after the index consultation, registered in eCAP
9. Number of complications related to the infection within 28 days after the index consultation registered in eCAP, such as visits to emergency departments and/or hospital admissions regarding the RTI
10. Number of days of work absenteeism due to the RTI registered in eCAP within the first 14 days
11. Difference in health-related quality of life on days 14 and 28, compared to baseline, measured using the EQ-5D-5L instrument
12. Drug-associated adverse events related to the antibiotic assessed by review of medical notes (practice staff, the local study team, or both using a standard form to report these data) within the first 14 days
13. Early clinical assessment based on the overall score at Day 7, defined as the total symptom score reported by the patient on that day (mean/median)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Institut Universitari D Investigacio En Atencion Primaria Jordi Gol

Sponsor organisation

Institut Universitari D Investigacio En Atencion Primaria Jordi Gol

Address

Gran Via De Les Corts Catalanes 587

City

Barcelona

Postcode

08007

Country

Spain

Scientific contact point

Organisation

Institut Universitari D Investigacio En Atencion Primaria Jordi Gol

Contact name

Carl Llor

Public contact point

Organisation

Institut Universitari D Investigacio En Atencion Primaria Jordi Gol

Contact name

Ramon Monfà

Locations

1 EU/EEA country · 18 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications