Status:
COMPLETED
Combined Use of a Respiratory Broad Panel mPCR and Procalcitonin to Reduce Duration of Antibiotics Exposure in Patients With Severe Community-Acquired Pneumonia
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Community-acquired Pneumonia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To assess the effectiveness of a management strategy combining a broad panel respiratory mPCR and an algorithm of early antibiotic de-escalation and discontinuation based on both the mPCR results and ...
Detailed Description
Randomization is performed immediately after the inclusion. * In the intervention arm, a broad panel respiratory mPCR is performed on a lower respiratory tract sample (bronchoalveolar lavage fluid or...
Eligibility Criteria
Inclusion
- Adults (≥18 years) with CAP admitted to the ICU since 18 hours or less; the diagnosis of pneumonia includes two clinical criteria among a temperature \> 37.8°C, tachypnea (respiratory rate \> 25/min), chest pain, cough, expectoration, localized crackles, with or without signs of pleural effusion, pulse oximetry less than 92% while breathing room air, and a newly-appeared parenchymal infiltrate; the pneumonia is community-acquired if the time between hospital admission and ICU referral is below or equal to 48 hours.
- Informed consent or emergency procedure.
Exclusion
- Pregnancy;
- Congenital immunodeficiency;
- HIV infection with the lymphocyte CD4 count below 200/mm3 or unknown in the last year;
- Acute hematologic malignancy;
- Neutropenia (\<1 leucocyte/mL or \< 0.5 neutrophil/mL);
- Immunosuppressive drugs within the previous 30 days, including anti-cancer chemotherapy and anti-rejection drugs for organ/bone marrow transplant
- Corticosteroids ≥ 20 mg/d of prednisone equivalent for more than 14 days;
- chronic obstructive pulmonary disease (COPD) with previous history of colonization/infection with Pseudomonas aeruginosa;
- Tracheostomy;
- Diffuse bronchiectasis, cystic fibrosis;
- Aspiration pneumonia;
- Moribund patient or death expected from underlying disease during the current admission;
- Patient deprived of liberty or under legal protection measure;
- Participation in another interventional trial.
Key Trial Info
Start Date :
October 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2023
Estimated Enrollment :
411 Patients enrolled
Trial Details
Trial ID
NCT03452826
Start Date
October 4 2018
End Date
March 1 2023
Last Update
October 18 2023
Active Locations (1)
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1
Hôpital BICHAT
Paris, France, 75018