Unknown statusInterventionalPhase 2Updated May 20, 2020
"Baricitinib for Treating Hospital-acquired Pneumonia in Critically Ill Patients With a Proinflammatory Phenotype. | NCT05914584 | Trialant
Unknown statusInterventionalPhase 2Phase 3Updated Jun 22, 2023
"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.
ClinicalTrials.gov ID
NCT05914584
Lead Sponsor
Nantes University HospitalOTHER
Overall Status
Unknown status
Study Type
Interventional
Phase
Phase 2Phase 3
Enrollment
450Estimated
Last Update Posted
Jun 22, 2023Actual
Start Date
Jul 1, 2023Estimated
Primary Completion Date
Aug 31, 2025Estimated
Completion Date
Dec 31, 2025Estimated
Official Title
"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.
Brief 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
Diagnosis of HAP according to European guidelines : association of two clinical criteria (body temperature > 38°c and purulent pulmonary secretions), the appearance of a new infiltrate or change in an existing infiltrate on chest radography, and respiratory sample (AET, BAL, mini-BAL or blind BAL) collected for bacteriological diagnosis (results can be pending at inclusion). The diagnosis of HAP can have been made outside of ICU
VAP : patients should have received machenical ventilation via an endotracheal or nasotracheal tube for the least 48h at the time of HAP diagnosis. V-HAP : patients should have been hospitalized for the least 48 hours before the onset of the first signs or symptoms and required invasive mechanical ventilation during HAP treatment
Biological systemic inflammatory response defined according to the on-site standard of acre (CPR > 125 mg/L and/or PCT > 2µg/L and/or ferritin blood level > 650 ng/mL
Receiving antimicrobal therapy for the current episode of HAP pneumonia for less than 72 hours
Informed consent from legal representative or emergency procedure (when possible according to national regulation). If it's 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 helth insurance scheme
Exclusion Criteria:
Pregnant women (serum or urine test), breastfeeding woment
Patient under legal protection (inc. under guardianship or trusteesheep)
Hypersensitivity to baricitinib
Uncontrolled herpes zoster, viral hepatitis, infection with human immunodeficiency virus, fungal infections or 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/1.73 m²)
Immunosuppression (hematologic cancer, aplasia, chemotherapy/radiotherapy for cancer within 3 months prior to the inclusion or anti-graft rejection drug)