Antibiotic Therapy In Respiratory Tract Infections

• Status: Not yet recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary aim: to demonstrate that stopping antibiotic treatment in patients diagnosed with acute community acquired 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 aims: To compare the 2 study arms on:

1. Clinical success at late follow up (Day 30),

2. Duration of antibiotic treatment,

3. Frequency and severity of adverse events,

4. Patient's pneumonia symptoms and quality of life.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Anti-Bacterial Agents; Anti-Infective Agents; Antibiotics, Antitubercular; Oxymetazoline

Criteria

Inclusion Criteria:

• Patient aged 18 years or more

• Has given written informed consent

• Affiliated to Health insurance

• Is able to take oral treatment

• 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

Exclusion Criteria:

All subjects meeting any of the following exclusion criteria at baseline will be excluded from study participation:

• 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

• Baseline oxygen saturation < 90% or home oxygen therapy

• More than 24 hours of antibiotics prior to consultation

• Any other infection necessitating concomitant antibiotic treatment

• 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, arterial hypertension, atherosclerosis only for patients treated with fluoroquinolones antibiotics

• Pregnancy

• Breastfeeding

• Life expectancy < 1 month

• Patient under legal guardianship or without healthcare coverage

• Homeless patient

• Patient enrolled in another interventional clinical trial.