EUCTR2019-001873-10-FR
Active, not recruiting
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Community acquired pneumonia
- Sponsor
- ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS
- Enrollment
- 310
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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,
- •\- 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
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\<400/mm3, sickle\-cell disease, Child\-Pugh class C cirrhosis)
- •Suspected or confirmed legionellosis
- •Atrial fibrillation / constitutive tachycardia (heart rate \> 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
- •Breastfeeding
- •Life expectancy \< 1 month
Outcomes
Primary Outcomes
Not specified
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