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

NCT05914584 | Unknown Phase 2

• 1 other identifier: RC22_0522
• Study Type: interventional
• Target: 450
• Locations: 4 countries
• Sites: 29

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.

Conditions

Hospital-acquired Pneumonia

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Day 28

Secondary Outcomes (24)

• To demonstrate the efficacy of baricitinib on pneumonia-associated morbidity reduction

  Day 28

• To demonstrate the efficacy of baricitinib on pneumonia-associated mortality reduction

  Day 28

• To demonstrate the efficacy of baricitinib on pneumonia-associated morbidity

  Month 3 and Month 6

• To demonstrate the efficacy of baricitinib on pneumonia-associated mortality

  Month 3 and Month 6

• To demonstrate the efficacy of baricitinib on pneumonia-associated morbidity reduction

  Day 28

Other Outcomes (13)

• Determine the safety of baricitinib

  Day 10-12

• Determine if baricitinib increases the economic efficiency of the treatment of pneumonia

  6 months

• Determine the suitability of baricitinib from the patient's perspectives

  Up to 6 months

Study Arms (2)

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

Drug: Baricitinib 4 MG

Standard of care alone

SHAM COMPARATOR

Same as described in arm 1

Drug: Baricitinib 4 MG

Interventions

Baricitinib 4 MG DRUG

Reference drug

Baricitinib + Standard of care; Standard of care alone

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ventilators-associated pneumonia (VAP) or hospital -acquired pneumonia requiring invasive ventilation (V-HAP)
• 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
• Person insured under a helth insurance scheme

You may not qualify if:

• 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)
• Recent (\<90 days) trhomboembolic event (venous trhombosis, pulmonary embolism, myocardial infarction, and/or stroke)

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (29)

St-Luc Clinics

Brussels, Belgium

Location

Ghent University Hospital

Ghent, Belgium

Location

Groupe Jolimont

Haine-Saint-Paul, Belgium

Location

Clinique Saint-Pierre

Ottignies, Belgium

Location

University Hospital of UCL Namur

Yvoir, Belgium

Location

CHU Angers

Angers, France

Location

CHU de Brest

Brest, France

Location

CHU de Caen

Caen, France

Location

CHU Clermont-Ferrand

Clermont-Ferrand, France

Location

CHU de Clermont-Ferrand

Clermont-Ferrand, France

Location

CHU de Clermont-Ferrand

Clermont-Ferrand, France

Location

CH La Roche sur Yon

La Roche-sur-Yon, France

Location

CHU de Limoges

Limoges, France

Location

CHU de Marseille

Marseille, France

Location

CHU de Nancy

Nancy, France

Location

CHU de Nantes

Nantes, France

Location

CHU de Nantes

Nantes, France

Location

CHU de Nantes

Nantes, France

Location

CHU de Nantes

Nantes, France

Location

CHU de Beaujon

Paris, France

Location

CHU la Pitié-Salpétrière

Paris, France

Location

CHU Pitié-Salpétrière

Paris, France

Location

CHU de Poitiers

Poitiers, France

Location

CHU de Rennes

Rennes, France

Location

CHU de Rennes

Rennes, France

Location

University Medical Center Utrecht

Utrecht, Netherlands

Location

Hospital Clinic

Barcelona, Spain

Location

Hospital del Mar

Barcelona, Spain

Location

Hospital Vall d'Hebron

Barcelona, Spain

Location

MeSH Terms

Conditions

Healthcare-Associated Pneumonia

Interventions

baricitinib

Condition Hierarchy (Ancestors)

Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Antoine ROQUILLY

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Astrid GARREAU

CONTACT

+33 (0) 2 53 48 28 40; astrid.garreau@chu-nantes.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: June 22, 2023
• Study Start: July 1, 2023
• Primary Completion: August 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

ES (3); BE (5); NL (1); FR (20)