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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.
EU CTIS ID: 2023-503480-42-00
What this study is testing
The primary objectives of this randomized trial are first 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.
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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)
See the full eligibility 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
- 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)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.