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

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS0 个研究点目标入组 310 人开始时间: 2019年7月19日最近更新: 2020年6月8日

适应症

试验速览

暂无简介。

•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
•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

•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
•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.

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