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

NCT06269900 | Recruiting Phase 3 DMC

• 1 other identifier: RC23_0358
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 26

Brief 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.

Conditions

Hospital Acquired Pneumonia

Outcome Measures

Primary Outcomes (2)

• Clinical cure rate at the test-of-cure visit (TOC visit)

  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).

  Day 8-10

• The rate of all-cause mortality on Day 28.

  Day 28

Secondary Outcomes (14)

• Rate of death

  Month 3 , Month 6

• Rate of pleural empyema at Day 28.

  Day 28

• Rate of microbiological failure

  Toc 1 day visit

• Rate of pneumonia relapse

  day 28

• Duration of hospitalization and hospital-free days

  Month 6

Study Arms (2)

dexamethasone + standard of care

EXPERIMENTAL

* Dexamethasone 0.2mg.kg-1.day-1 intravenous for a minimal duration of 5 days, and a maximal duration of 7 days in case of persistence of ARDS criteria (PaO2/FiO2 ratio \< 300). * Standard of care: antimicrobial therapy in compliance with European guidelines. Briefly, intravenous antimicrobial therapy with the narrowest spectrum to cover at-risk and/or identified pathogens for 7-8 days.

Drug: Dexamethasone

Placebo + Standard of care

PLACEBO COMPARATOR

* Placebo 0.2mg.kg-1.day-1 intravenous for 5 days and a maximal duration of 7 days in case of persistence of ARDS criteria (PaO2/FiO2 ratio \< 300). * Standard of care: antimicrobial therapy in compliance with European guidelines. Briefly, intravenous antimicrobial therapy with the narrowest spectrum to cover at-risk and/or identified pathogens for 7-8 days.

Drug: Placebo

Interventions

Dexamethasone DRUG

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

dexamethasone + standard of care

Placebo DRUG

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

Placebo + Standard of care

Eligibility Criteria

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

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (26)

Chu Amiens

Amiens, France

RECRUITING

CHU Angers

Angers, France

RECRUITING

Chu Bordeaux

Bordeaux, France

RECRUITING

Chu Bordeaux

Bordeaux, France

NOT YET RECRUITING

CHU Brest

Brest, France

RECRUITING

CHU Caen

Caen, France

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

RECRUITING

CHU Raymond Poincaré

Garches, France

RECRUITING

Chu Grenoble

Grenoble, France

RECRUITING

CHU Limoges

Limoges, France

RECRUITING

CHU Marseille

Marseille, France

RECRUITING

Chu Nancy

Nancy, France

RECRUITING

CHU Nantes (HGRL)

Nantes, 44000, France

RECRUITING

CHU Nantes

Nantes, 44000, France

RECRUITING

CHU Nantes (HGRL)

Nantes, France

RECRUITING

Chu Nimes

Nîmes, France

RECRUITING

CHU Pitié Salpétrière

Paris, France

RECRUITING

CHU Pitié Salpétrière

Paris, France

RECRUITING

CHU Poitiers

Poitiers, France

RECRUITING

CHU Rennes

Rennes, France

RECRUITING

CHU Rennes

Rennes, France

RECRUITING

Chu Strasbourg

Strasbourg, France

RECRUITING

Chu Toulouse

Toulouse, France

NOT YET RECRUITING

MeSH Terms

Conditions

Healthcare-Associated Pneumonia

Interventions

Dexamethasone

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

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Antoine ROQUILLY

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antoine ROQUILLY

CONTACT

+33253482876; antoine.roquilly@chu-nantes.fr

Lucile MARGUET

CONTACT

+33253482876; lucile.marguet@chu-nantes.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 21, 2024
• Study Start: March 26, 2024
• Primary Completion: March 14, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: August 11, 2025

Record last verified: 2025-08

Locations

FR (26)