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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-85
SponsorNantes University Hospital

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Dexamethasone
  • Placebo

Treatment groups

450 Participants
are divided into 2 treatment groups

Sponsors and collaborators