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Dexamethasone for Treating Severe Hospital-acquired Pneumonia in Critically Ill Patients With a Proinflammatory Phenotype | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

Dexamethasone for Treating Severe Hospital-acquired Pneumonia in Critically Ill Patients With a Proinflammatory Phenotype, an International Phase III, Double-blind, Placebo-controlled, Randomized Trial

NCT06269900•Nantes University Hospital

View on ClinicalTrials.gov

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

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

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.
+5 more criteria

Locations (26)

Chu Amiens

Amiens, France

CHU Angers

Angers, France

Chu Bordeaux

Bordeaux, France

Chu Bordeaux

Bordeaux, France

CHU Brest

Brest, France

CHU Caen

Caen, France

CHU Clermont - Ferrand

Clermont-Ferrand, France

CHU Clermont-Ferrand

Clermont-Ferrand, France

CHU Clermont-Ferrand

Clermont-Ferrand, France

CHU Beaujon

Clichy, France

Key Dates

Start Date

March 26, 2024

Primary Completion Date

March 14, 2026

Completion Date

August 15, 2026

Last Updated

August 11, 2025

Enrollment

450

ESTIMATED participants

Conditions

Hospital Acquired Pneumonia

Interventions

Dexamethasone

DRUG

Placebo

DRUG

Contacts

Antoine ROQUILLY

CONTACT

+33253482876 antoine.roquilly@chu-nantes.fr

Lucile MARGUET

CONTACT

+33253482876 lucile.marguet@chu-nantes.fr

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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