Dexamethasone for Treating Severe Hospital-acquired Pneumonia in Critically Ill Patients With a Proinflammatory Phenotype
NCT ID: NCT06269900
Last Updated: 2025-08-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
450 participants
INTERVENTIONAL
2024-03-26
2026-08-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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dexamethasone + standard of care
* 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.
Dexamethasone
Dexamethasone phosphate injection is given as a slow injection or infusion (intravenous drip) into the veins.
Placebo + Standard of care
* 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.
Placebo
Placebo injection is given as a slow injection or infusion (intravenous drip) into the veins.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
85 Years
ALL
No
Sponsors
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Nantes University Hospital
OTHER
Responsible Party
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Principal Investigators
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Antoine ROQUILLY
Role: PRINCIPAL_INVESTIGATOR
Nantes University Hospital
Locations
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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
CHU Raymond Poincaré
Garches, , France
Chu Grenoble
Grenoble, , France
CHU Limoges
Limoges, , France
CHU Marseille
Marseille, , France
Chu Nancy
Nancy, , France
CHU Nantes (HGRL)
Nantes, , France
CHU Nantes
Nantes, , France
CHU Nantes (HGRL)
Nantes, , France
Chu Nimes
Nîmes, , France
CHU Pitié Salpétrière
Paris, , France
CHU Pitié Salpétrière
Paris, , France
CHU Poitiers
Poitiers, , France
CHU Rennes
Rennes, , France
CHU Rennes
Rennes, , France
Chu Strasbourg
Strasbourg, , France
Chu Toulouse
Toulouse, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RC23_0358
Identifier Type: -
Identifier Source: org_study_id
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