Hospital-acquired PneumoniaPhase 2/3TREAT-HAPNCT05914584
"Baricitinib for Treating Hospital-acquired Pneumonia in Critically Ill Patients With a Proinflammatory Phenotype.
A Phase 2/3 study testing Baricitinib 4 MG in people with Hospital-acquired Pneumonia, run by Nantes University Hospital at 29 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hospital-acquired Pneumonia
- What is being tested?
- Baricitinib 4 MG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- 29 sitesin 4 countries
- Study dates
- 1 Jul 2023to 31 Dec 2025
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
29 sites in 4 countries.
29 sites in 4 countries
France20 sites
CHU Angers
Angers
Sigismond LASOCKI, +33 (0) 2 41 35 36 35, silasocki@chu-angers.fr
CHU de Brest
Brest
Xavier CHAPALAIN, +33 (0) 2 98 22 33 33, xavier.chapalain@chu-brest.fr
CHU de Caen
Caen
Clément GAKUBA, +33 (0)2 31 06 31 06, gakuba-c@chu-caen.fr
CHU Clermont-Ferrand
Clermont-Ferrand
Pierre COUHAULT, +33 (0) 4 73 75 07 50, couhault@chu-clermontferrand.fr
CHU de Clermont-Ferrand
Clermont-Ferrand
Lucie AUPETITGENDRE, +33 (0)4 73 75 06 12, laupetitgendre@chu-clermontferrand.fr
CHU de Clermont-Ferrand
Clermont-Ferrand
Russell CHABANNE, +33 (0)4 73 75 16 48, rchabanne@chu-clermontferrand.fr
CH La Roche sur Yon
La Roche-sur-Yon
Maude MILLEREUX, +33 (0) 2 51 44 61 61, maud.millereux@ght85.fr
CHU de Limoges
Limoges
Bruno FRANCOIS, +33 (0) 5 55 05 62 74, bruno.francois@chu-limoges.fr
CHU de Marseille
Marseille
Marc LEONE, +33 (0)4 91 96 86 50, marc.leone@ap-hm.fr
CHU de Nancy
Nancy
Gérard AUDIBERT, +33 (0)3 83 85 96 50, g.audibert@chru-nancy.fr
CHU de Nantes
Nantes
Antoine ROQUILLY, +33 (0) 2 53 48 22 30, antoine.roquilly@chu-nantes.fr
CHU de Nantes
Nantes
Karim LAKHAL, +33 (0) 2 40 16 53 04, karim.lakhal@chu-nantes.fr
CHU de Nantes
Nantes
Mickaël VOURC'H, +33 (0) 2 40 16 80 53, mickael.vourch@chu-nantes.fr
CHU de Nantes
Nantes
Jean-Baptise LASCARROU, +33 (0) 2 40 08 73 76, jeanbaptiste.lascarrou@chu-nantes.fr
CHU de Beaujon
Paris
Emmanuel WEISS, +33 (0) 1 40 87 44 03, emmanuel.weiss@aphp.fr
CHU la Pitié-Salpétrière
Paris
Vincent DEGOS, +33 (0) 1 42 16 33 71, vincent.degos@inserm.fr
CHU Pitié-Salpétrière
Paris
Jean-Michel CONSTANTIN, +33 (0) 1 42 16 33 71, jean-michel.constantin@aphp.fr
CHU de Poitiers
Poitiers
Claire DAHYOT FIZELIER, +33 (0) 5 49 44 44 44, fizelier@chu-poitiers.fr
CHU de Rennes
Rennes
Yoann LAUNEY, +33 (0) 99 288 42 46, yoann.launey@chu-rennes.fr
CHU de Rennes
Rennes
Jean-Marc TADIE, +33 (0) 2 99 28 42 48, jeanmarc.tadie@chu-rennes.fr
Belgium5 sites
St-Luc Clinics
Brussels
Jean-Baptiste MESLAND, +32/2 764 27 51, baptiste.mesland@saintluc.uclouvain.be
Ghent University Hospital
Ghent
Pieter DEPUYDT, +32/9 332 28 08, pieter.depuydt@ugent.be
Groupe Jolimont
Haine-Saint-Paul
Vincent HUBERLANT, +32/6 423 40 40, vincent.huberlant@jolimont.be
Clinique Saint-Pierre
Ottignies
Nicolas DE SCHRYVER, +32/1 043 77 34, nicolas.deschryver@cspo.be
University Hospital of UCL Namur
Yvoir
Patrick HONORE, +32/4 781 22 50, patrick.honore@chuuclnamur.uclouvain.be
Spain3 sites
Hospital Clinic
Barcelona
Antoni TORRES, +34/93 227 5549, atorres@clinic.cat
Hospital del Mar
Barcelona
Rosana MUNOZ, +34/93 248 30 41, rmunozbermudez@psmar.cat
Hospital Vall d'Hebron
Barcelona
Ricard FERRER, +34/93 274 62 09, r.ferrer@vhebron.net
Netherlands1 site
University Medical Center Utrecht
Utrecht
Lennie DERDE, +31/887 555 555, lderde@umcutrecht.nl
About this study
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.
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.
Read the 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
- Being tested
- Baricitinib 4 MG
- Medical subject headings
- Healthcare-Associated Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baricitinib 4 MGDrug
Reference drug
| Study group | Role | What they receive |
|---|---|---|
| Baricitinib + Standard of care | Experimental | 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 Receives: Drug: Baricitinib 4 MG |
| Standard of care alone | Sham comparator | Same as described in arm 1 Receives: Drug: Baricitinib 4 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Day 28
Secondary outcomes (24)
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.
Measured: Day 28
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.
Measured: Day 28
To demonstrate the efficacy of baricitinib on pneumonia-associated morbidity
All-cause morbidity at Month 3 and Month 6
Measured: Month 3 and Month 6
To demonstrate the efficacy of baricitinib on pneumonia-associated mortality
All-cause mortality at Month 3 and Month 6
Measured: Month 3 and Month 6
To demonstrate the efficacy of baricitinib on pneumonia-associated morbidity reduction
Rate of pleural empyema at Day 28.
Measured: Day 28
To demonstrate the efficacy of baricitinib on pneumonia-associated mortality reduction
Presence of pleural empyema at Day 28.
Measured: 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)
Measured: Day 28
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)
Measured: Day 28
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)
Measured: Up to 28 days
To demonstrate the efficacy of baricitinib on pneumonia-associated mortality reduction
Rate of pneumonia relapse
Measured: Up to 28 days
To demonstrate the efficacy of baricitinib on pneumonia-associated mortality reduction
Time course of body temperature
Measured: Up to Day 28
To demonstrate the efficacy of baricitinib on pneumonia-associated mortality reduction
Cardiac pulse rate
Measured: Up to Day 28
To demonstrate the efficacy of baricitinib on pneumonia-associated mortality reduction
Oxygen saturation
Measured: Up to Day 28
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)
Measured: Up to Day 28
To demonstrate the efficacy of baricitinib on pneumonia-associated mortality reduction
Leukocyte counts (every 48 hours) for 12 days
Measured: Up to Day 12
To demonstrate the efficacy of baricitinib on pneumonia-associated mortality reduction
Pa02/FiO2
Measured: Day 28
To demonstrate the efficacy of baricitinib on pneumonia-associated mortality reduction
Rates of non respiratory hospital-acquired infections
Measured: Day 28
To demonstrate the efficacy of baricitinib on pneumonia-associated morbidity reduction
Rates of nonrespiratory hospital-acquired infections
Measured: Day 28
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.
Measured: Day 28
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.
Measured: Day 28
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.
Measured: Up to Month 3
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.
Measured: Up to Month 3
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.
Measured: Up to Month 3
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)
Measured: Up to Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start1 Jul 2023 (estimated)
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hospital-acquired PneumoniaStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine ROQUILLY, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05914584
- Sponsor's protocol ID
- RC22_0522
- Acronym
- TREAT-HAP
- Status last verified
- Jun 2023
- First submitted
- 19 Apr 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05914584
- Acronym / sponsor ID
- TREAT-HAP / RC22_0522
- Conditions
- Hospital-acquired Pneumonia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baricitinib + Standard of care | Experimental | Drug: Baricitinib 4 MGBaricitinib 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 |
| Standard of care alone | Sham comparator | Drug: Baricitinib 4 MGSame as described in arm 1 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baricitinib 4 MGReference drug | Drug | Baricitinib + Standard of care, Standard of care alone |
Primary outcome
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
Time frame: Day 28
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
Time frame: Day 28
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
24 secondary outcomes
To demonstrate the efficacy of baricitinib on pneumonia-associated morbidity reduction
Time frame: Day 28
To demonstrate the efficacy of baricitinib on pneumonia-associated mortality reduction
Time frame: Day 28
To demonstrate the efficacy of baricitinib on pneumonia-associated morbidity
Time frame: Month 3 and Month 6
To demonstrate the efficacy of baricitinib on pneumonia-associated mortality
Time frame: Month 3 and Month 6
To demonstrate the efficacy of baricitinib on pneumonia-associated morbidity reduction
Time frame: Day 28
To demonstrate the efficacy of baricitinib on pneumonia-associated mortality reduction
Time frame: Day 28
To demonstrate the efficacy of baricitinib on pneumonia-associated morbidity reduction
Time frame: Day 28
To demonstrate the efficacy of baricitinib on pneumonia-associated mortality reduction
Time frame: Day 28
To demonstrate the efficacy of baricitinib on pneumonia-associated morbidity reduction
Time frame: Up to 28 days
To demonstrate the efficacy of baricitinib on pneumonia-associated mortality reduction
Time frame: Up to 28 days
To demonstrate the efficacy of baricitinib on pneumonia-associated mortality reduction
Time frame: Up to Day 28
To demonstrate the efficacy of baricitinib on pneumonia-associated mortality reduction
Time frame: Up to Day 28
To demonstrate the efficacy of baricitinib on pneumonia-associated mortality reduction
Time frame: Up to Day 28
To demonstrate the efficacy of baricitinib on pneumonia-associated mortality reduction
Time frame: Up to Day 28
To demonstrate the efficacy of baricitinib on pneumonia-associated mortality reduction
Time frame: Up to Day 12
To demonstrate the efficacy of baricitinib on pneumonia-associated mortality reduction
Time frame: Day 28
To demonstrate the efficacy of baricitinib on pneumonia-associated mortality reduction
Time frame: Day 28
To demonstrate the efficacy of baricitinib on pneumonia-associated morbidity reduction
Time frame: Day 28
To demonstrate the efficacy of baricitinib on pneumonia-associated morbidity reduction
Time frame: Day 28
To demonstrate the efficacy of baricitinib on pneumonia-associated mortality reduction
Time frame: Day 28
To demonstrate the efficacy of baricitinib on pneumonia-associated morbidity reduction
Time frame: Up to Month 3
To demonstrate the efficacy of baricitinib on pneumonia-associated mortality reduction
Time frame: Up to Month 3
To demonstrate the efficacy of baricitinib on pneumonia-associated mortality reduction
Time frame: Up to Month 3
To demonstrate the efficacy of baricitinib on pneumonia-associated morbidity reduction
Time frame: Up to Month 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoine ROQUILLY principal investigator
Nantes University Hospital
29 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Baricitinib 4 MG in people with Hospital-acquired Pneumonia, run by Nantes University Hospital at 29 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in France, Belgium, Spain, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Astrid GARREAU (+33 (0) 2 53 48 28 40, astrid.garreau@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Day 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.