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

Study acronym: HAP-DEX
StatusRecruiting
PhasePhase 3
Started2024-03-26
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 9 months later Mar 14, 2026 → Dec 15, 2026
See other at-risk trials from Nantes University Hospital

Amendment history

2026-08-16
critical
Study Status, Contacts/Locations, Document Section v3
Trial sites expanded: 26 → 34 locations
Primary completion pushed: 2026-03-14 → 2026-12-15
Completion pushed: 2026-08-15 → 2027-03-15
2025-08-05
minor
Study Status, Arms and Interventions, Eligibility, Contacts/Locations v2
Eligibility criteria+556 characters
[...] ital admission. HAP severity defined as a PaO2/FiO2 ratio < 200300 under invasive mechanical ventilation. Biological systemic inflammatory response defined as CPR>≥ 150 mg/L (15 mg/dL)* Receiving curative antimicrobial thera [...] h effective contraception for the 28 first days of the study:. Exclusion Criteria: Pregnant women (serum or urine test), b [...] 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 implementati [...]
Study sitesdetails revised at 8 of 26 sites
2024-12-03
notable
Not Yet Recruiting→Recruiting Study Status, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-02-15→confirmed 2024-03-26
Study sites17→26
Eligibility criteria+114 characters
[...] lines (Torres et al. Eur Respir J 2017): Association of two clinicalcriteria criteriaamong (body temperature > 38°C, leukocytosis>12000 cells per mL, leucopenia <4000 cells per mL and purulent pulmonary secretions), appearance of a new inf [...] ion). The diagnosis of HAP can have been made outside of ICU. Diagnosis butis done at least 48 hours after hospital admission. SeverityHAP severity defined as a PaO2/FiO2 ratio < 200 under invasive mechanica [...] for COVID-19 infection requiring supplemental oxygen therapy a Severe septic shock (norepinephrine > 0.4 microg/kg/min and [...] te level greater than 2 mmol/L) [...]
2024-02-20
minor
Original filing
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.
Trial Details
NCT Number NCT06269900
Lead Sponsor Nantes University Hospital
Conditions Hospital Acquired Pneumonia
Enrollment 450 participants
Start Date 2024-03-26
Primary Completion 2026-12-15 (estimated)
Study Completion 2027-03-15 (estimated)
Updated on ClinicalTrials.gov 2026-08-19