ANTIBIOTIC THERAPY IN RESPIRATORY TRACT INFECTIONS

Phase 1

• Conditions: Community acquired pneumonia; MedDRA version: 20.1Level: LLTClassification code 10010120Term: Community acquired pneumoniaSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2019-001873-10-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-19
• Last Update Posted: 8 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 310

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

•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
•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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified