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

Primary Purpose

Hospital-acquired Pneumonia

Status
Not yet recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Baricitinib 4 MG
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hospital-acquired Pneumonia

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Ventilators-associated pneumonia (VAP) or hospital -acquired pneumonia requiring invasive ventilation (V-HAP) 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) Persistent anemia (haemoglobin < 8 g/L), lymphopenia (absolute lymphocyte < 500 cells/mm3) Immunosuppression (hematologic cancer, aplasia, chemotherapy/radiotherapy for cancer within 3 months prior to the inclusion or anti-graft rejection drug) Recent (<90 days) trhomboembolic event (venous trhombosis, pulmonary embolism, myocardial infarction, and/or stroke) Participation to an interventional drug study within 1 month prior to the inclusion

Sites / Locations

  • St-Luc Clinics
  • Ghent University Hospital
  • Groupe Jolimont
  • Clinique Saint-Pierre
  • University Hospital of UCL Namur
  • CHU Angers
  • CHU de Brest
  • CHU de Caen
  • CHU Clermont-Ferrand
  • CHU de Clermont-Ferrand
  • CHU de Clermont-Ferrand
  • CH La Roche sur Yon
  • CHU de Limoges
  • CHU de Marseille
  • CHU de Nancy
  • CHU de Nantes
  • CHU de Nantes
  • CHU de Nantes
  • CHU de Nantes
  • CHU de Beaujon
  • CHU la Pitié-Salpétrière
  • CHU Pitié-Salpétrière
  • CHU de Poitiers
  • CHU de Rennes
  • CHU de Rennes
  • University Medical Center Utrecht
  • Hospital del Mar
  • Hospital Vall d'Hebron
  • Hospital Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Baricitinib + Standard of care

Standard of care alone

Arm Description

Baricitinib injected per os for 10 days (4mg/day). the first administration of this treatment is performed within the 6 hours following the randomization, followed by daily administration for a total of 10 days. The standard of care : for treating HAP will comply with international guidelines. For all patients, empiri antimicrobial therapy is initiated imedialty after collecting the respiratory sample and can thus be started before the randomization to avoid delayed antimicrobial therapy. Its recommanded to broaden the spectrum in case of resistant bacteria resistant to the empirical antimicrobial therapy but il is not recommanded to prolong the antibiotic tratment for more than 7-8 days

Same as described in arm 1

Outcomes

Primary Outcome Measures

Determine the safety (phase II), 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
Using a hierarchic procedure. We will test the baricitinib superiority on the clinical cure rate at the test-of-cure visit realized 10-12 days after randomization or at the ICU discharge. If the superiority criterion is met at the test-of-cure visit, we will test the baricitinib superiority on the rate of all-cause mortality on Day 28
Determine the 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
Using a hierarchic procedure. We will test the baricitinib superiority on the clinical cure rate at the test-of-cure visit realized 10-12 days after randomization or at the ICU discharge. If the superiority criterion is met at the test-of-cure visit, we will test the baricitinib superiority on the rate of all-cause mortality on Day 28

Secondary Outcome Measures

To demonstrate the efficacy of baricitinib on pneumonia-associated morbidity reduction
In case of a non-significant difference in the rate of clinical cure, the co-primary outcome will be presented as a secondary outcome.
To demonstrate the efficacy of baricitinib on pneumonia-associated mortality reduction
In case of a non-significant difference in the rate of clinical cure, the co-primary outcome will be presented as a secondary outcome.
To demonstrate the efficacy of baricitinib on pneumonia-associated morbidity
All-cause morbidity at Month 3 and Month 6
To demonstrate the efficacy of baricitinib on pneumonia-associated mortality
All-cause mortality at Month 3 and Month 6
To demonstrate the efficacy of baricitinib on pneumonia-associated morbidity reduction
Rate of pleural empyema at Day 28.
To demonstrate the efficacy of baricitinib on pneumonia-associated mortality reduction
Presence of pleural empyema at Day 28.
To demonstrate the efficacy of baricitinib on pneumonia-associated morbidity reduction
Rate of microbial failure (defined as a positive respiratory culture at the ToC visit)
To demonstrate the efficacy of baricitinib on pneumonia-associated mortality reduction
Rate of microbial failure (defined a a positive respiratory culture at the ToC visit)
To demonstrate the efficacy of baricitinib on pneumonia-associated morbidity reduction
Rate of pneumonia relapse (defined as a second episode of HAP with one r more identical pathogens, rate of pneumonia recurrence (defined as a second epsode of AP with different pathogens)
To demonstrate the efficacy of baricitinib on pneumonia-associated mortality reduction
Rate of pneumonia relapse
To demonstrate the efficacy of baricitinib on pneumonia-associated mortality reduction
Time course of body temperature
To demonstrate the efficacy of baricitinib on pneumonia-associated mortality reduction
Cardiac pulse rate
To demonstrate the efficacy of baricitinib on pneumonia-associated mortality reduction
Oxygen saturation
To demonstrate the efficacy of baricitinib on pneumonia-associated mortality reduction
Type of mechanical ventilation support (invasive, noninvasive, none) (daily evaluation at 8.00am and 8.00pm)
To demonstrate the efficacy of baricitinib on pneumonia-associated mortality reduction
Leukocyte counts (every 48 hours) for 12 days
To demonstrate the efficacy of baricitinib on pneumonia-associated mortality reduction
Pa02/FiO2
To demonstrate the efficacy of baricitinib on pneumonia-associated mortality reduction
Rates of non respiratory hospital-acquired infections
To demonstrate the efficacy of baricitinib on pneumonia-associated morbidity reduction
Rates of nonrespiratory hospital-acquired infections
To demonstrate the efficacy of baricitinib on pneumonia-associated morbidity reduction
Antibiotic-free days (the number of antibiotic-free days is defined as the number of days between Day 1 and Day 28 for which living patients do not receive antibiotics.
To demonstrate the efficacy of baricitinib on pneumonia-associated mortality reduction
Antibiotic-free days (the number of antibiotic-free days is defined as the number of days between Day 1 and Day 28). Dead patients will be ascribed 0 antibiotic-free days.
To demonstrate the efficacy of baricitinib on pneumonia-associated morbidity reduction
Duration of invasive mechanical ventilation and invasive mechanical ventilation-free days (defined as the number of days between Day 1 and Month 3 for which living patients breath spontaneously.
To demonstrate the efficacy of baricitinib on pneumonia-associated mortality reduction
Duration of invasive mechanical ventilation and invasive mechanical ventilation-free days (defined as the number of days between Day 1 and Month 3). Dead patients will be ascribed 0 mechanical ventilation-free days.
To demonstrate the efficacy of baricitinib on pneumonia-associated mortality reduction
Duration ogf hospitalization and hospital-free days (the number of hospital-free days is defined as the number of days between Day 1 and Month 3 which living patients are outside of a hospital.
To demonstrate the efficacy of baricitinib on pneumonia-associated morbidity reduction
Duration ogf hospitalization and hospital-free days (the number of hospital-free days is defined as the number of days between Day 1 and Month 3). Dead patients will be ascribed 0 hospital-fre days)

Full Information

First Posted
April 19, 2023
Last Updated
June 13, 2023
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05914584
Brief Title
"Baricitinib for Treating Hospital-acquired Pneumonia in Critically Ill Patients With a Proinflammatory Phenotype.
Acronym
TREAT-HAP
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
August 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hospital-acquired Pneumonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Baricitinib + Standard of care
Arm Type
Experimental
Arm Description
Baricitinib injected per os for 10 days (4mg/day). the first administration of this treatment is performed within the 6 hours following the randomization, followed by daily administration for a total of 10 days. The standard of care : for treating HAP will comply with international guidelines. For all patients, empiri antimicrobial therapy is initiated imedialty after collecting the respiratory sample and can thus be started before the randomization to avoid delayed antimicrobial therapy. Its recommanded to broaden the spectrum in case of resistant bacteria resistant to the empirical antimicrobial therapy but il is not recommanded to prolong the antibiotic tratment for more than 7-8 days
Arm Title
Standard of care alone
Arm Type
Sham Comparator
Arm Description
Same as described in arm 1
Intervention Type
Drug
Intervention Name(s)
Baricitinib 4 MG
Intervention Description
Reference drug
Primary Outcome Measure Information:
Title
Determine the safety (phase II), 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
Description
Using a hierarchic procedure. We will test the baricitinib superiority on the clinical cure rate at the test-of-cure visit realized 10-12 days after randomization or at the ICU discharge. If the superiority criterion is met at the test-of-cure visit, we will test the baricitinib superiority on the rate of all-cause mortality on Day 28
Time Frame
Day 28
Title
Determine the 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
Description
Using a hierarchic procedure. We will test the baricitinib superiority on the clinical cure rate at the test-of-cure visit realized 10-12 days after randomization or at the ICU discharge. If the superiority criterion is met at the test-of-cure visit, we will test the baricitinib superiority on the rate of all-cause mortality on Day 28
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
To demonstrate the efficacy of baricitinib on pneumonia-associated morbidity reduction
Description
In case of a non-significant difference in the rate of clinical cure, the co-primary outcome will be presented as a secondary outcome.
Time Frame
Day 28
Title
To demonstrate the efficacy of baricitinib on pneumonia-associated mortality reduction
Description
In case of a non-significant difference in the rate of clinical cure, the co-primary outcome will be presented as a secondary outcome.
Time Frame
Day 28
Title
To demonstrate the efficacy of baricitinib on pneumonia-associated morbidity
Description
All-cause morbidity at Month 3 and Month 6
Time Frame
Month 3 and Month 6
Title
To demonstrate the efficacy of baricitinib on pneumonia-associated mortality
Description
All-cause mortality at Month 3 and Month 6
Time Frame
Month 3 and Month 6
Title
To demonstrate the efficacy of baricitinib on pneumonia-associated morbidity reduction
Description
Rate of pleural empyema at Day 28.
Time Frame
Day 28
Title
To demonstrate the efficacy of baricitinib on pneumonia-associated mortality reduction
Description
Presence of pleural empyema at Day 28.
Time Frame
Day 28
Title
To demonstrate the efficacy of baricitinib on pneumonia-associated morbidity reduction
Description
Rate of microbial failure (defined as a positive respiratory culture at the ToC visit)
Time Frame
Day 28
Title
To demonstrate the efficacy of baricitinib on pneumonia-associated mortality reduction
Description
Rate of microbial failure (defined a a positive respiratory culture at the ToC visit)
Time Frame
Day 28
Title
To demonstrate the efficacy of baricitinib on pneumonia-associated morbidity reduction
Description
Rate of pneumonia relapse (defined as a second episode of HAP with one r more identical pathogens, rate of pneumonia recurrence (defined as a second epsode of AP with different pathogens)
Time Frame
Up to 28 days
Title
To demonstrate the efficacy of baricitinib on pneumonia-associated mortality reduction
Description
Rate of pneumonia relapse
Time Frame
Up to 28 days
Title
To demonstrate the efficacy of baricitinib on pneumonia-associated mortality reduction
Description
Time course of body temperature
Time Frame
Up to Day 28
Title
To demonstrate the efficacy of baricitinib on pneumonia-associated mortality reduction
Description
Cardiac pulse rate
Time Frame
Up to Day 28
Title
To demonstrate the efficacy of baricitinib on pneumonia-associated mortality reduction
Description
Oxygen saturation
Time Frame
Up to Day 28
Title
To demonstrate the efficacy of baricitinib on pneumonia-associated mortality reduction
Description
Type of mechanical ventilation support (invasive, noninvasive, none) (daily evaluation at 8.00am and 8.00pm)
Time Frame
Up to Day 28
Title
To demonstrate the efficacy of baricitinib on pneumonia-associated mortality reduction
Description
Leukocyte counts (every 48 hours) for 12 days
Time Frame
Up to Day 12
Title
To demonstrate the efficacy of baricitinib on pneumonia-associated mortality reduction
Description
Pa02/FiO2
Time Frame
Day 28
Title
To demonstrate the efficacy of baricitinib on pneumonia-associated mortality reduction
Description
Rates of non respiratory hospital-acquired infections
Time Frame
Day 28
Title
To demonstrate the efficacy of baricitinib on pneumonia-associated morbidity reduction
Description
Rates of nonrespiratory hospital-acquired infections
Time Frame
Day 28
Title
To demonstrate the efficacy of baricitinib on pneumonia-associated morbidity reduction
Description
Antibiotic-free days (the number of antibiotic-free days is defined as the number of days between Day 1 and Day 28 for which living patients do not receive antibiotics.
Time Frame
Day 28
Title
To demonstrate the efficacy of baricitinib on pneumonia-associated mortality reduction
Description
Antibiotic-free days (the number of antibiotic-free days is defined as the number of days between Day 1 and Day 28). Dead patients will be ascribed 0 antibiotic-free days.
Time Frame
Day 28
Title
To demonstrate the efficacy of baricitinib on pneumonia-associated morbidity reduction
Description
Duration of invasive mechanical ventilation and invasive mechanical ventilation-free days (defined as the number of days between Day 1 and Month 3 for which living patients breath spontaneously.
Time Frame
Up to Month 3
Title
To demonstrate the efficacy of baricitinib on pneumonia-associated mortality reduction
Description
Duration of invasive mechanical ventilation and invasive mechanical ventilation-free days (defined as the number of days between Day 1 and Month 3). Dead patients will be ascribed 0 mechanical ventilation-free days.
Time Frame
Up to Month 3
Title
To demonstrate the efficacy of baricitinib on pneumonia-associated mortality reduction
Description
Duration ogf hospitalization and hospital-free days (the number of hospital-free days is defined as the number of days between Day 1 and Month 3 which living patients are outside of a hospital.
Time Frame
Up to Month 3
Title
To demonstrate the efficacy of baricitinib on pneumonia-associated morbidity reduction
Description
Duration ogf hospitalization and hospital-free days (the number of hospital-free days is defined as the number of days between Day 1 and Month 3). Dead patients will be ascribed 0 hospital-fre days)
Time Frame
Up to Month 3
Other Pre-specified Outcome Measures:
Title
Determine the safety of baricitinib
Description
Rate of serious adverse effects and suspected unexpected serious adverse reaction (SUSAR) at Day 28. Rate of neutropenia, lymphopenia and trhombocytosis at the test-of-cure visit (Day 10-12). Rates of drug-induced liver injury defined by the International DILI Expert Working Groups as ALT greater than or equal to 5 or ALP greater than or equal to 2 and TBL inferior to 2 ULN (corresponding to grade 1, mild severity) Rate of acute kidney failure (KDIO 2-3) at the test-of-cure visit (Day 10-12) Rate of major trhombo-embolic events at the test-of-cure visit (Days 10-12), rate of EKG modification at the test-of-cure visit (Day10-12)
Time Frame
Day 10-12
Title
Determine if baricitinib increases the economic efficiency of the treatment of pneumonia
Description
Cost-effictiveness analysis (CEA) using QALYs (Quality-Adjusted Life-Years) will consist in estmating an incremental cost-effectiveness ratio (ICER)
Time Frame
6 months
Title
Determine the suitability of baricitinib from the patient's perspectives
Description
Changes in health-related quality of life after randomization measured with the Short Form-36 scale validated in French, Spanish, Flemish and Dutch. These questionnaires will be filled in by the patient (patient's perspective) or by one relative if the patient cannot respond for him/herself (patient's perspective).
Time Frame
Up to 6 months
Title
Determine the suitability of baricitinib from the patient's perspectives
Description
Changes in anxiety and depression measured with the Hospital and Aanxiety Depression scale validated in French, Spanish, Flemish and Dutch. These questionnaires will be filled in by the patient (patient's perspective) or by one relative if the patient cannot respond for him/herself (patient's perspective).
Time Frame
Up to 6 months
Title
Determine the suitability of baricitinib from the patient's perspectives
Description
Changes in subjective well-being measured with the Satisfaction With Life Scale (SWLS) validated in French, Spanish, Flemish and Dutch.
Time Frame
Up to 6 months
Title
To identify biomarkers for stratidication of patents into responders and non-responders to baricitinib
Description
To capture the complexity of the host-pathogens interactions and to clinically validate biomarkers for the stratification of patients into low/high risk of poor outcomes of HAP and responders/non responders to immunotherapy
Time Frame
Day 10-12
Title
To identify a biobank of blood and respiratory samples collected from humans with hospital-acquired pneumonia
Description
Collection of respiratory fluid and blood for biobank
Time Frame
Day 10-12
Title
Determine the safety of baricitinib
Description
Rate of serious adverse effects and suspected unexpected serious adverse reaction (SUSAR) at Day 28.
Time Frame
Day 28
Title
Determine the safety of baricitinib
Description
Rate of neutropenia, lymphopenia and thrombocytosis at the test-of-cure visit
Time Frame
Day 10-12
Title
Determine the safety of baricitinib
Description
Rates of drug-induced liver injury defined by the International DILI Expert Working Groups as ALT greater than or equal to 5 or ALP greater than or equal to 2 and TBL inferior to 2 ULN (corresponding to grade 1, mild severity)
Time Frame
Day 10-12
Title
Determine the safety of baricitinib
Description
Rate of acute kidney failure (KDIO 2-3) at the test-of-cure visit
Time Frame
Day 10-12
Title
Determine the safety of baricitinib
Description
Rate of major thrombo-embolic events at the test-of-cure visit
Time Frame
Day 10-12
Title
Determine the safety of baricitinib
Description
Rate of EKG modification at the test-of-cure visit
Time Frame
Day 10-12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ventilators-associated pneumonia (VAP) or hospital -acquired pneumonia requiring invasive ventilation (V-HAP) 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) Persistent anemia (haemoglobin < 8 g/L), lymphopenia (absolute lymphocyte < 500 cells/mm3) Immunosuppression (hematologic cancer, aplasia, chemotherapy/radiotherapy for cancer within 3 months prior to the inclusion or anti-graft rejection drug) Recent (<90 days) trhomboembolic event (venous trhombosis, pulmonary embolism, myocardial infarction, and/or stroke) Participation to an interventional drug study within 1 month prior to the inclusion
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Astrid GARREAU
Phone
+33 (0) 2 53 48 28 40
Email
astrid.garreau@chu-nantes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoine ROQUILLY
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St-Luc Clinics
City
Bruxelles
Country
Belgium
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Baptiste MESLAND
Phone
+32/2 764 27 51
Email
baptiste.mesland@saintluc.uclouvain.be
Facility Name
Ghent University Hospital
City
Ghent
Country
Belgium
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pieter DEPUYDT
Phone
+32/9 332 28 08
Email
pieter.depuydt@ugent.be
Facility Name
Groupe Jolimont
City
Haine-Saint-Paul
Country
Belgium
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent HUBERLANT
Phone
+32/6 423 40 40
Email
vincent.huberlant@jolimont.be
Facility Name
Clinique Saint-Pierre
City
Ottignies
Country
Belgium
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas DE SCHRYVER
Phone
+32/1 043 77 34
Email
nicolas.deschryver@cspo.be
Facility Name
University Hospital of UCL Namur
City
Yvoir
Country
Belgium
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick HONORE
Phone
+32/4 781 22 50
Email
patrick.honore@chuuclnamur.uclouvain.be
Facility Name
CHU Angers
City
Angers
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sigismond LASOCKI
Phone
+33 (0) 2 41 35 36 35
Email
silasocki@chu-angers.fr
Facility Name
CHU de Brest
City
Brest
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xavier CHAPALAIN
Phone
+33 (0) 2 98 22 33 33
Email
xavier.chapalain@chu-brest.fr
Facility Name
CHU de Caen
City
Caen
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clément GAKUBA
Phone
+33 (0)2 31 06 31 06
Email
gakuba-c@chu-caen.fr
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre COUHAULT
Phone
+33 (0) 4 73 75 07 50
Email
couhault@chu-clermontferrand.fr
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucie AUPETITGENDRE
Phone
+33 (0)4 73 75 06 12
Email
laupetitgendre@chu-clermontferrand.fr
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Russell CHABANNE
Phone
+33 (0)4 73 75 16 48
Email
rchabanne@chu-clermontferrand.fr
Facility Name
CH La Roche sur Yon
City
La Roche-sur-Yon
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maude MILLEREUX
Phone
+33 (0) 2 51 44 61 61
Email
maud.millereux@ght85.fr
Facility Name
CHU de Limoges
City
Limoges
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruno FRANCOIS
Phone
+33 (0) 5 55 05 62 74
Email
bruno.francois@chu-limoges.fr
Facility Name
CHU de Marseille
City
Marseille
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc LEONE
Phone
+33 (0)4 91 96 86 50
Email
marc.leone@ap-hm.fr
Facility Name
CHU de Nancy
City
Nancy
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gérard AUDIBERT
Phone
+33 (0)3 83 85 96 50
Email
g.audibert@chru-nancy.fr
Facility Name
CHU de Nantes
City
Nantes
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoine ROQUILLY
Phone
+33 (0) 2 53 48 22 30
Email
antoine.roquilly@chu-nantes.fr
Facility Name
CHU de Nantes
City
Nantes
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karim LAKHAL
Phone
+33 (0) 2 40 16 53 04
Email
karim.lakhal@chu-nantes.fr
Facility Name
CHU de Nantes
City
Nantes
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mickaël VOURC'H
Phone
+33 (0) 2 40 16 80 53
Email
mickael.vourch@chu-nantes.fr
Facility Name
CHU de Nantes
City
Nantes
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Baptise LASCARROU
Phone
+33 (0) 2 40 08 73 76
Email
jeanbaptiste.lascarrou@chu-nantes.fr
Facility Name
CHU de Beaujon
City
Paris
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuel WEISS
Phone
+33 (0) 1 40 87 44 03
Email
emmanuel.weiss@aphp.fr
Facility Name
CHU la Pitié-Salpétrière
City
Paris
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent DEGOS
Phone
+33 (0) 1 42 16 33 71
Email
vincent.degos@inserm.fr
Facility Name
CHU Pitié-Salpétrière
City
Paris
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Michel CONSTANTIN
Phone
+33 (0) 1 42 16 33 71
Email
jean-michel.constantin@aphp.fr
Facility Name
CHU de Poitiers
City
Poitiers
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire DAHYOT FIZELIER
Phone
+33 (0) 5 49 44 44 44
Email
fizelier@chu-poitiers.fr
Facility Name
CHU de Rennes
City
Rennes
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoann LAUNEY
Phone
+33 (0) 99 288 42 46
Email
yoann.launey@chu-rennes.fr
Facility Name
CHU de Rennes
City
Rennes
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Marc TADIE
Phone
+33 (0) 2 99 28 42 48
Email
jeanmarc.tadie@chu-rennes.fr
Facility Name
University Medical Center Utrecht
City
Utrecht
Country
Netherlands
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lennie DERDE
Phone
+31/887 555 555
Email
lderde@umcutrecht.nl
Facility Name
Hospital del Mar
City
Barcelona
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosana MUNOZ
Phone
+34/93 248 30 41
Email
rmunozbermudez@psmar.cat
Facility Name
Hospital Vall d'Hebron
City
Barcelona
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ricard FERRER
Phone
+34/93 274 62 09
Email
r.ferrer@vhebron.net
Facility Name
Hospital Clinic
City
Barcelone
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoni TORRES
Phone
+34/93 227 5549
Email
atorres@clinic.cat

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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