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

Status: Recruiting
Location: See all (26) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Chu Amiens
RECRUITING
Amiens
CHU Angers
RECRUITING
Angers
Chu Bordeaux
RECRUITING
Bordeaux
Chu Bordeaux
NOT_YET_RECRUITING
Bordeaux
CHU Brest
RECRUITING
Brest
CHU Caen
RECRUITING
Caen
CHU Clermont - Ferrand
RECRUITING
Clermont-ferrand
CHU Clermont-Ferrand
RECRUITING
Clermont-ferrand
CHU Clermont-Ferrand
RECRUITING
Clermont-ferrand
CHU Beaujon
RECRUITING
Clichy
CHU Raymond Poincaré
RECRUITING
Garches
Chu Grenoble
RECRUITING
Grenoble
CHU Limoges
RECRUITING
Limoges
CHU Marseille
RECRUITING
Marseille
Chu Nancy
RECRUITING
Nancy
CHU Nantes
RECRUITING
Nantes
CHU Nantes (HGRL)
RECRUITING
Nantes
CHU Nantes (HGRL)
RECRUITING
Nantes
Chu Nimes
RECRUITING
Nîmes
CHU Pitié Salpétrière
RECRUITING
Paris
CHU Pitié Salpétrière
RECRUITING
Paris
CHU Poitiers
RECRUITING
Poitiers
CHU Rennes
RECRUITING
Rennes
CHU Rennes
RECRUITING
Rennes
Chu Strasbourg
RECRUITING
Strasbourg
Chu Toulouse
NOT_YET_RECRUITING
Toulouse
Contact Information
Primary
Antoine ROQUILLY
antoine.roquilly@chu-nantes.fr
+33253482876
Backup
Lucile MARGUET
lucile.marguet@chu-nantes.fr
+33253482876
Time Frame
Start Date: 2024-03-26
Estimated Completion Date: 2026-08-15
Participants
Target number of participants: 450
Treatments
Experimental: dexamethasone + standard of care
* Dexamethasone 0.2mg.kg-1.day-1 intravenous for a minimal duration of 5 days, and a maximal duration of 7 days in case of persistence of ARDS criteria (PaO2/FiO2 ratio \< 300).~* Standard of care: antimicrobial therapy in compliance with European guidelines. Briefly, intravenous antimicrobial therapy with the narrowest spectrum to cover at-risk and/or identified pathogens for 7-8 days.
Placebo_comparator: Placebo + Standard of care
* Placebo 0.2mg.kg-1.day-1 intravenous for 5 days and a maximal duration of 7 days in case of persistence of ARDS criteria (PaO2/FiO2 ratio \< 300).~* Standard of care: antimicrobial therapy in compliance with European guidelines. Briefly, intravenous antimicrobial therapy with the narrowest spectrum to cover at-risk and/or identified pathogens for 7-8 days.
Related Therapeutic Areas
Sponsors
Leads: Nantes University Hospital

This content was sourced from clinicaltrials.gov

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