NCT05914584

"Baricitinib for Treating Hospital-acquired Pneumonia in Critically Ill Patients With a Proinflammatory Phenotype.

"Baricitinib for Treating Hospital-acquired Pneumonia in Critically Ill Patients With a Proinflammatory Phenotype, an International Phase II/Phase III, Randomized, Controlled Trial - TREAT-HAP Study.

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to determine the safety (phase II), then efficacy (phase III) of baricitinib plus standard of care (SOC) as compared to SOC alone for the treatment of hospital-acquired pneumonia in patients with a pro-inflammatory profile.

Detailed description

For both groups : At inclusion visit : * Verification of inclusion and non-inclusion criteria * Patient information and signature of consent form * Pregnancy test (urine ou blood) * Randomization * Clinical evaluation (cardiac frequency, saturation, tracheal secretions, PaO2/FiO2 ratio, body temperature, mechanical ventilation support) * Collection of respiratory fluid and blood for biobank * Liver function test (AST, ALT, bilirubin), blood white cells count and EKG * Treatment compliance * Concomitant medications (antimicrobial therapy and steriods) * Survival and EQ-5D-5L At visit 1 to visit 10 ( Day1- day10) * Clinical evaluation (cardiac frequency, saturation, tracheal secretions, PaO2/FiO2 ratio, body temperature, mechanical ventilation support) * Study drug administration (daily) * Collection of respiratory fluid and blood for biobank (day 3 and day 7) * Liver function test (AST, ALT, bilirubin), blood white cells count and EKG (Liver, day 3 and day 7) * Treatment compliance * Adverse event * Concomitant medications (antimicrobial therapy and steriods) At visit 11(Day 10-12 test-of-cure) : * Clinical evaluation (cardiac frequency, saturation, tracheal secretions, PaO2/FiO2 ratio, body temperature, mechanical ventilation support) * Collection of respiratory fluid and blood for biobank * Collection of the respiratory fluid for bacterial cure * Liver function test (AST, ALT, bilirubin), blood white cells count and EKG * Adverse event * Concomitant medications (antimicrobial therapy and steriods) At visit 12 : * Adverse event * Survival and EQ-5D-5L At visit 13 (month 3) and visit 14 (month 6) : * Query in NHI Database (SNDS) for consumption of Health resources (pharmaceuticals, consultations...) * Survival and EQ-5D-5L * Health -related quality of the life (SF-36), anxiety/depression (HADS), subjective well-being (SWLS) * Interview with a researcher in pshychology (20 patients and their relatives - only in France)

Conditions

• Hospital-acquired Pneumonia

Interventions

Type	Name	Description
DRUG	Baricitinib 4 MG	Reference drug

Timeline

• Start date: 2023-07-01
• Primary completion: 2025-08-31
• Completion: 2025-12-31
• First posted: 2023-06-22
• Last updated: 2023-06-22

Locations

29 sites across 4 countries: Belgium, France, Netherlands, Spain