Ireland
--:--IST
Recruiting Phase 3

Dexamethasone for Treating Severe Hospital-acquired Pneumonia in Critically Ill Patients With a Proinflammatory Phenotype

NCT06269900 · tracked via the Priya Life Science France tracker
Phase
Phase 3
Started
2024-03-26
Last updated
2026-08-19

Condition(s) studied

Hospital Acquired Pneumonia

Investigational drug(s) / intervention(s)

Dexamethasone →Placebo

Dexamethasone: Dexamethasone phosphate injection is given as a slow injection or infusion (intravenous drip) into the veins.

Placebo: Placebo injection is given as a slow injection or infusion (intravenous drip) into the veins.

Study summary

Determine the efficacy of dexamethasone plus standard of care (SOC) as compared to placebo plus SOC for treating severe hospital-acquired pneumonia in critically ill patients with a proinflammatory phenotype; It's an international phase III, double-blind, placebo-controlled, randomized trial.

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: * Hospital-acquired pneumonia (HAP) according to European guidelines (Torres et al. Eur Respir J 2017): Association of two criteria among (body temperature \> 38°C, leukocytosis\>12000 cells per mL, leucopenia \<4000 cells per mL and purulent pulmonary secretions), appearance of a new infiltrate or change in an existing infiltrate on chest radiography, and respiratory sample (Sputum, 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. Diagnosis is done at least 48 hours after hospital admission. * HAP severity defined as a PaO2/FiO2 ratio \< 300 under mechanical ventilation. * Biological systemic inflammatory response defined as CPR≥ 150 mg/L (15 mg/dL)\* * Receiving curative antimicrobial therapy for the current episode of HAP pneumonia for less than 48 hours. * Informed consent from a legal representative, or emergency procedure (when possible, according to national regulation, see below). If it is not possible to obtain the patient consent prior 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. * Female of childbearing age who agree and who are able to comply with effective contraception for the 28 first days of the study. Exclusion Criteria: * Pregnant women (serum or urine test), breastfeeding women. * Patient under legal protection (incl. under guardianship or trusteeship). * Hypersensitivity to dexamethasone and hypersensitivity to all of its excipients * Ongoing administration of glucocorticoid at the time of randomisation, such as for COVID-19 infection requiring supplemental oxygen therapy * Severe septic shock (norepinephrine \> 0.4 microg/kg/min and serum lactate level greater than 2 mmol/L) at the time of randomisation * Prolonged use of corticosteroids at a mean minimum dose of 0.3 mg/kg/day of prednisone equivalent for \>3 weeks in the past 60 days * Uncontrolled viral (hepatitis,herpes, zona, varicella) or systemic fungal infection * Immunosuppression pre-existing to hospitalisation (severe lymphopenia \< 500 lymphocytes/mm3, hematologic cancer, aplasia, chemotherapy/radiotherapy for cancer within 3 months prior to the inclusion, or anti-graft rejection drug). * Uncontrolled psychotic disorder (acute or chronical) * Patients not expected to survive for more than 48 hours. * Participation in another drug clinical trial : * testing steroids or anti-graft rejection drug or chemotherapy- radiotherapy for cancer * And / Or testing a drug regimen with a known interaction with dexamethasone, * And / Or whose implementation would alter the HAP-DEX 6-month follow-up, notably the collection of the primary outcome. * Situations that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study

Primary outcome measure(s)

  • Clinical cure rate at the test-of-cure visit (TOC visit) — Day 8-10
    It's a hierarchic procedure. First, we will test the dexamethasone superiority on the clinical cure rate at the test-of-cure visit realized 8 days (acceptable time frame Day 8-10) after randomization or at the ICU discharge (if it occurs before).
  • The rate of all-cause mortality on Day 28. — Day 28

Trial sites (34)

FacilityCityRegionStatus
Chu Amiens Amiens France Active Not Recruiting
CHU Angers Angers France Recruiting
Chu Bordeaux Bordeaux France Recruiting
Chu Bordeaux Bordeaux France Recruiting
CHU Brest Brest France Recruiting
CHU Caen Caen France Active Not Recruiting
CHU Clermont - Ferrand Clermont-Ferrand France Recruiting
CHU Clermont-Ferrand Clermont-Ferrand France Recruiting
CHU Clermont-Ferrand Clermont-Ferrand France Recruiting
CHU Beaujon Clichy France Active Not Recruiting
CHU Raymond Poincaré Garches France Recruiting
Chu Grenoble Grenoble France Active Not Recruiting
CHU Limoges Limoges France Recruiting
CHU Marseille Marseille France Recruiting
Chu Montpellier Montpellier France Active Not Recruiting
Chu Nancy Nancy France Active Not Recruiting
CHU Nantes (HGRL) Nantes France Recruiting
CHU Nantes Nantes France Recruiting
CHU Nantes (HGRL) Nantes France Recruiting
Chu Nimes Nîmes France Active Not Recruiting
CHU Pitié Salpétrière Paris France Active Not Recruiting
GHU Paris Psychiatrie et Neurosciences Paris France Recruiting
CHU Poitiers Poitiers France Recruiting
CHU Rennes Rennes France Recruiting
CHU Rennes Rennes France Recruiting
Chu Rennes Rennes France Recruiting
Chu Strasbourg Strasbourg France Active Not Recruiting
Chu Toulouse Toulouse France Not Yet Recruiting
Evaggelismos Hospital Athens Greece Completed
Thoracic Genral Hsopital of Athens Athens Greece Completed
KAT General Hospital of Athens, Kifissia Greece Active Not Recruiting
General hospital of Larisas Larissa Greece Completed
General Hospital Of LArissa Larissa Greece Completed
Hospital Clínic Barcelona Barcelona Spain Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06269900 on ClinicalTrials.gov ↗ ← All trials in France