Baricitinib for treating hospital-acquired pneumonia in critically ill patients with a proinflammatory phenotype, an international phase II / phase III, randomized, controlled trial - the TREAT-HAP study.

Phase 1

Conditions: Hospital-acquired pneumonia
MedDRA version: 20.0Level: LLTClassification code: 10076918Term: Hospital acquired pneumonia Class: 10021881
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: CTIS2023-503480-42-00

Lead Sponsor: Centre Hospitalier Universitaire De Nantes

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 450

Inclusion Criteria

Adult patients (18yr to 85yr), Ventilator-associated pneumonia (VAP) or hospital-acquired pneumonia requiring invasive ventilation (V-HAP), Biological systemic inflammatory response defined according to the on-site standard of care, Receiving antimicrobial therapy for the current episode of HAP pneumonia for less than 72 hours, Informed consent from a legal representative, or emergency procedure (when possible, according to national regulation, see below). If it is impossible to obtain patient consent before the inclusion (comatose patients), patient consent for the study continuation will be obtained as soon as deemed possible, Person insured under a health insurance scheme

Exclusion Criteria

Pregnant women (serum or urine test), breastfeeding women, Recent (<90 days) thromboembolic event, Active COVID 19 pneumonia ( PCR or antigen detection within the last 7 days), chronic or recurrent infection, cancer in the last year, active long time smokers ( > 20 years), Participation to an interventional drug study within 1 month before to the inclusion, Patient under legal protection (incl. under guardianship or trusteeship), Hypersensitivity to baricitinib, Uncontrolled herpes zoster, active viral hepatitis, infection with human immunodeficiency virus, active fungal infections, or active tuberculosis, Severe hepatic insufficiency (Child-Pugh B or C), Acute or chronic renal insufficiency (Modification of Diet in Renal Disease (MDRD) Creatinine Clearance < 30 ml/min/1.73m2) or renal replacement therapy, Persistent anemia (haemoglobin < 8 g/L), lymphopenia (absolute lymphocyte < 500 cells/mm3), or neutropenia (absolute neutrophil count <1,000 cells/mm3), Immunosuppression (hematologic cancer, aplasia, chemotherapy/radiotherapy for cancer within 3 months prior to the inclusion, or anti-graft rejection drug)