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Using dexamethasone to treat severe hospital-acquired pneumonia in critically ill patients

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

Phase 3 Interventional Nantes University Hospital · NCT06269900

This study is testing if adding dexamethasone to standard treatment helps critically ill patients with severe hospital-acquired pneumonia feel better compared to those who only get standard treatment.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment450 (estimated)
Ages18 Years to 85 Years
SexAll
SponsorNantes University Hospital Academic / other
Drugs / interventionschemotherapy, prednisone
Locations26 sites (Amiens and 25 other locations)
Trial IDNCT06269900 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of dexamethasone combined with standard care compared to a placebo with standard care for patients suffering from severe hospital-acquired pneumonia (HAP) who exhibit a proinflammatory phenotype. It is an international phase III, double-blind, placebo-controlled, randomized trial designed to provide robust evidence on the treatment's efficacy. The study will include critically ill patients who meet specific criteria related to their pneumonia severity and inflammatory response.

Who should consider this trial

Good fit: Ideal candidates for this study are critically ill patients diagnosed with severe hospital-acquired pneumonia and exhibiting a proinflammatory phenotype.

Not a fit: Patients who do not have severe hospital-acquired pneumonia or those who are not critically ill may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for critically ill patients with severe hospital-acquired pneumonia.

How similar studies have performed: Other studies have explored the use of corticosteroids in pneumonia treatment, showing varying degrees of success, but this specific approach in critically ill patients is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Amiens and 25 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Hospital Acquired Pneumonia
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.