se of a respiratory multiplex PCR and procalcitonin to reduce antibiotic exposure in patients with severe confirmed COVID-19 pneumonia

Phase 1

• Conditions: Severe confirmed COVID-19 pneumonia; MedDRA version: 20.0Level: LLTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2020-001324-33-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS (APHP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-29
• Last Update Posted: 7 June 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 194

Inclusion Criteria

- Adults (>= 18 years) admitted to the ICU;
- Severe confirmed COVID-19 pneumonia, defined by i) a newly-appeared pulmonary parenchymal infiltrate; and ii) a positive RT-PCR (either upper or lower respiratory tract) for COVID-19 (SARS-CoV-2); iii) and admission to the ICU or intermediate care unit;
- Informed consent or emergency procedure.
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 97
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 97

Exclusion Criteria

- Pregnancy and breastfeeding women ;
- Congenital immunodeficiency;
- HIV infection with CD4 count below 200/mm3 or unknown in the last year;
- High-grade hematological malignancy;
- Neutropenia (<1 leucocyte/mL or < 0.5 neutrophil/mL);
- Immunosuppressive drugs within the previous 30 days, including anti-cancer cytotoxic chemotherapy and anti-rejection drugs for organ/bone marrow transplant;
- Moribund patient or death expected from underlying disease during the current admission;
- Patient deprived of liberty or under legal protection measure.

Study & Design

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