ANTIBIOTIC THERAPY IN RESPIRATORY TRACT INFECTIONS

ANTIBIOTIC THERAPY IN RESPIRATORY TRACT INFECTIONS: AIR. A controlled randomized, open label, multicenter, non-inferiority trial evaluating an individualized antibiotic duration treatment strategy based on patient clinical response, evaluated through connected devices, for community acquired pneumonia in community setting - AIR

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-001873-10-FR

Enrollment

310

Registered

2019-07-19

Start date

2020-04-03

Completion date

Unknown

Last updated

2024-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Community acquired pneumonia MedDRA version: 20.1 Level: LLT Classification code 10010120 Term: Community acquired pneumonia System Organ Class: 100000004862

Interventions

Product Name: AMOXICILLIN Pharmaceutical Form: Buccal tablet Product Name: AMOXICILLIN-CLAVULANATE Pharmaceutical Form: Buccal tablet Product Name: AMPICILLIN Pharmaceutical Form: Buccal tablet Pro

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Patient aged 18 years or more • Presenting with suspected CAP defined by all the followingthe presence of at least 2 of the following diagnostic clinical criteria: - Fever (temperature > 38°C) - Dyspnea, - Cough, - Production of purulent sputum, - Crackles - Radiological evidence of a new infiltrate (on chest X-ray or CT scan) • In need for antibiotic treatment targeting respiratory tract, according to the physician in charge • No other site of infection besides respiratory • Affiliated to Health insurance • Is able to take oral treatment • Has given written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 155 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 155

Exclusion criteria

Exclusion criteria: • Signs of severe CAP (abscess, massive pleural effusion, serious chronic respiratory insufficiency) • Hospitalization following consultation • Known immunosuppression (asplenia, neutropenia, agammaglobulinemia, immunosuppressive treatments or corticosteroids (prednisolone equivalent) > 10 mg/day, transplant, myeloma, lymphoma, known HIV and CD4 100/min) • Baseline oxygen saturation < 90% or home oxygen therapy • More than 24 hours of antibiotic treatment prior to consultation • Any other infection necessitating antibiotic treatment • Pregnancy • Breastfeeding • Life expectancy < 1 month • Patient under legal guardianship or without healthcare coverage • Homeless patient • Patient enrolled in another interventional clinical trial, • Concomitant steroid treatment only for patients treated with quinolones or fluoroquinolones antibiotics, • Pre-existing aortic aneurysm or dissection, family history of aortic aneurysm or dissection, Marfan syndrome, Ehlers-Danlos syndrome, Takayasu arthritis, arterial hypertension, atherosclerosis only for patients treated with quinolones or fluoroquinolones antibiotics.

Design outcomes

Primary

Measure	Time frame
Main Objective: Primary objective Demonstrate that stopping antibiotic treatment in patients diagnosed with acute Community Acquires Pneumonia (CAP) based on clinical response has a non-inferior efficacy 15 days after start of treatment, compared to a conventional predetermined duration left to the physician's judgement, in adults treated in the community setting. ;Secondary Objective: Secondary objectives To compare the 2 study arms on : •Clinical success at late follow up (Day 30) •Duration of antibiotic treatment •Adverse events (frequency and severity) •Patient's pneumonia symptoms and quality of life ;Primary end point(s): The primary endpoint is cure at Day 15 after the start of treatment. Cure is defined at Day 15 after the start of treatment by the association of: •Persistence of stability criteria (body temperature = 37.8°C; heart rate = 100/min; systolic blood pressure > 90mmHg; oxygen saturation = 90%; normal mental status); •Absence of worsening (stabilization or improvement) of clinical signs among those present on initial presentation: chest pain, coughing frequency or severity, sputum production, shortness of breath, crackles; •No additional antibiotic treatment, targeting respiratory tract infections, taken after the end of initial antibiotic treatment. ;Timepoint(s) of evaluation of this end point: At Day 15	—

Measure

Time frame

Main Objective: Primary objective Demonstrate that stopping antibiotic treatment in patients diagnosed with acute Community Acquires Pneumonia (CAP) based on clinical response has a non-inferior efficacy 15 days after start of treatment, compared to a conventional predetermined duration left to the physician's judgement, in adults treated in the community setting. ;Secondary Objective: Secondary objectives To compare the 2 study arms on : •Clinical success at late follow up (Day 30) •Duration of antibiotic treatment •Adverse events (frequency and severity) •Patient's pneumonia symptoms and quality of life ;Primary end point(s): The primary endpoint is cure at Day 15 after the start of treatment. Cure is defined at Day 15 after the start of treatment by the association of: •Persistence of stability criteria (body temperature = 37.8°C; heart rate = 100/min; systolic blood pressure > 90mmHg; oxygen saturation = 90%; normal mental status); •Absence of worsening (stabilization or improvement) of clinical signs among those present on initial presentation: chest pain, coughing frequency or severity, sputum production, shortness of breath, crackles; •No additional antibiotic treatment, targeting respiratory tract infections, taken after the end of initial antibiotic treatment. ;Timepoint(s) of evaluation of this end point: At Day 15

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Secondary

Measure	Time frame
Secondary end point(s): • Cure at Day 30 after the start of treatment defined by the association of: - Absence of worsening (stabilization or improvement) of clinical signs depending on initial presentation: chest pain, coughing frequency or severity, sputum production, shortness of breath; - Absence of additional antibiotic treatment needed after the end of initial antibiotic treatment. • Duration of antibiotic treatment • Frequency and severity of adverse events between the 2 study arms • Patients' evolution of pneumonia symptoms and quality of life between the 2 study arms (CAP Score / CAP Sym) ;Timepoint(s) of evaluation of this end point: At Day 30	—

Measure

Time frame

Secondary end point(s): • Cure at Day 30 after the start of treatment defined by the association of: - Absence of worsening (stabilization or improvement) of clinical signs depending on initial presentation: chest pain, coughing frequency or severity, sputum production, shortness of breath; - Absence of additional antibiotic treatment needed after the end of initial antibiotic treatment. • Duration of antibiotic treatment • Frequency and severity of adverse events between the 2 study arms • Patients' evolution of pneumonia symptoms and quality of life between the 2 study arms (CAP Score / CAP Sym) ;Timepoint(s) of evaluation of this end point: At Day 30

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Countries

France

Contacts

Public ContactSabrina Williams

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS

sabrina.williams@aphp.fr33144841770

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026