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AIR. ANTIBIOTIC THERAPY IN RESPIRATORY TRACT INFECTIONS A controlled randomized, open label, multicenter, non-inferiority trial evaluating an individualized antibiotic treatment duration based on patient clinical response, evaluated through connected devices, for suspected community acquired pneumonia in the community setting
EU CTIS ID: 2024-516097-30-00
What this study is testing
To demonstrate that stopping antibiotic treatment in patients diagnosed with acute 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
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patient aged 18 years or more
- Presenting with suspected CAP defined by the 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
- With home internet access (WIFI)
- Affiliated to health insurance
You likely can't join if
- Signs of severe CAP (abscess, massive pleural effusion, serious chronic respiratory insufficiency)
- Contraindications to the study antibiotics
- Concomitant steroid treatment only for patients treated with fluoroquinolones antibiotics
- Pre-existing aortic aneurysm or dissection, family history of aortic aneurysm or dissection, Marfan syndrome, Ehlers-Danlos syndrome, Takayasu arthritis, uncontrolled arterial hypertension, atherosclerosis only for patients treated with fluoroquinolones antibiotics
- Pregnancy
- Breastfeeding
See the full eligibility criteria
- Patient aged 18 years or more
- Presenting with suspected CAP defined by the 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
- With home internet access (WIFI)
- Affiliated to health insurance
- Is able to take oral treatment
- Has given written informed consent
- Signs of severe CAP (abscess, massive pleural effusion, serious chronic respiratory insufficiency)
- Contraindications to the study antibiotics
- Concomitant steroid treatment only for patients treated with fluoroquinolones antibiotics
- Pre-existing aortic aneurysm or dissection, family history of aortic aneurysm or dissection, Marfan syndrome, Ehlers-Danlos syndrome, Takayasu arthritis, uncontrolled arterial hypertension, atherosclerosis only for patients treated with fluoroquinolones antibiotics
- Pregnancy
- Breastfeeding
- Life expectancy < 1 month
- Patient under legal guardianship
- Homeless patient
- Patient unable to use the connected devices
- Patient enrolled in another interventional clinical trial
- Hospitalization following consultation
- Known immunosuppression (asplenia, neutropenia, agammaglobulinemia, immunosuppressive treatments or corticosteroids (prednisolone equivalent) > 10 mg/day, transplant, myeloma, lymphoma, known HIV and CD4<400/mm3, sickle-cell disease, Child-Pugh class C cirrhosis)
- Suspected or confirmed legionellosis
- Atrial fibrillation / constitutive tachycardia (usual heart rate > 100/min)
- Baseline oxygen saturation < 90%
- Home oxygen therapy
- More than 24 hours of antibiotics prior to consultation
- Any other infection necessitating concomitant antibiotic treatment
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.