nctId: NCT06269900 id: RC23_0358 briefTitle: Dexamethasone for Treating Severe Hospital-acquired Pneumonia in Critically Ill Patients With a Proinflammatory Phenotype acronym: HAP-DEX overallStatus: NOT_YET_RECRUITING date: 2024-02-15 date: 2026-03-14 date: 2026-08-15 date: 2024-02-21 date: 2024-02-21 name: Nantes University Hospital class: OTHER briefSummary: 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. conditions: Hospital Acquired Pneumonia studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 450 type: ESTIMATED name: Dexamethasone name: Placebo measure: Clinical cure rate at the test-of-cure visit (TOC visit) measure: The rate of all-cause mortality on Day 28. measure: Rate of death measure: Rate of pleural empyema at Day 28. measure: Rate of microbiological failure measure: Rate of pneumonia relapse measure: Duration of hospitalization and hospital-free days measure: Rates of non-respiratory hospital-acquired infection measure: Antibiotic-free days at Day 28 measure: Duration of invasive mechanical ventilation and invasive mechanical ventilation-free days measure: Rate of SUSAR ( suspected unexpected serious adverse reaction) and AE ( Adverse event) measure: Rate of gastric ulcer measure: Anxiety and depression were measured with the HADS (Hospital Anxiety and Depression Scale measure: Changes in subjective well-being with the Satisfaction With Life Scale (SWLS) measure: Changes in health-related quality of life measured with the Short Form (SF)-36 measure: the cost-effectiveness analysis (CEA ) will estimate an incremental cost-effectiveness ratio (ICER) sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU Angers city: Angers country: France lat: 47.46667 lon: -0.55 facility: CHU Brest city: Brest country: France name: Xavier CHAPALAIN role: CONTACT email: xavier.chapalain@chu-brest.fr lat: 48.3903 lon: -4.48628 facility: CHU Caen city: Caen country: France name: Clément GAKUBA role: CONTACT email: gakuba-c@chu-caen.fr lat: 49.18585 lon: -0.35912 facility: CHU Clermont - Ferrand city: Clermont-Ferrand country: France name: Russell CHABANNE role: CONTACT email: rchabanne@chu-clermontferrand.fr lat: 45.77966 lon: 3.08628 facility: CHU Clermont-Ferrand city: Clermont-Ferrand country: France lat: 45.77966 lon: 3.08628 facility: CHU Clermont-Ferrand city: Clermont-Ferrand country: France name: Pierre COUHAULT role: CONTACT email: couhault@chu-clermontferrand.fr lat: 45.77966 lon: 3.08628 facility: CHU Beaujon city: Clichy country: France name: Emmanuel WEISS role: CONTACT email: emmanuel.weiss@aphp.fr lat: 48.90018 lon: 2.30952 facility: CHU Limoges city: Limoges country: France name: Bruno FRANCOIS role: CONTACT email: bruno.francois@chu-limoges.fr lat: 45.83153 lon: 1.25781 facility: CHU Marseille city: Marseille country: France name: Marc LEONE role: CONTACT email: marc.leone@ap-hm.fr lat: 43.29551 lon: 5.38958 facility: CHU Nancy city: Nancy country: France name: Gérard AUDIBERT role: CONTACT email: g.audibert@chru-nancy.fr lat: 48.68439 lon: 6.18496 facility: CHU Nantes (HGRL) city: Nantes zip: 44000 country: France lat: 47.21725 lon: -1.55336 facility: CHU Nantes city: Nantes zip: 44000 country: France name: Antoine ROQUILLY role: CONTACT phone: +33253482835 email: antoine.roquilly@chu-nantes.fr lat: 47.21725 lon: -1.55336 facility: CHU Nantes (HGRL) city: Nantes country: France name: Mickael VOURC'H role: CONTACT email: mickael.vourch@chu-nantes.fr lat: 47.21725 lon: -1.55336 facility: CHU Pitié Salpétrière city: Paris country: France lat: 48.85341 lon: 2.3488 facility: CHU Poitiers city: Poitiers country: France name: Claire DAHYOT FIZELIER role: CONTACT email: claire.dahyot-fizelier@chu-poitiers.fr lat: 46.58333 lon: 0.33333 facility: CHU Rennes city: Rennes country: France name: Yoann LAUNEY role: CONTACT email: yoann.launey@chu-rennes.fr lat: 48.11198 lon: -1.67429 facility: CHU Rennes city: Rennes country: France name: Jean-Marc TADIE role: CONTACT email: jeanmarc.tadie@chu-rennes.fr lat: 48.11198 lon: -1.67429 hasResults: False