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