NCT06269900 Dexamethasone for Treating Severe Hospital-acquired Pneumonia in Critically Ill Patients With a Proinflammatory Phenotype
| NCT ID | NCT06269900 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Nantes University Hospital |
| Condition | Hospital Acquired Pneumonia |
| Study Type | INTERVENTIONAL |
| Enrollment | 450 participants |
| Start Date | 2024-03-26 |
| Primary Completion | 2026-12-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 450 participants in total. It began in 2024-03-26 with a primary completion date of 2026-12-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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 * Severe septic shock (norepinephrine \> 0.4 microg/kg/min and serum lactate level greater than 2 mmol/L) at the time of randomisation * Prolonged use of corticosteroids at a mean minimum dose of 0.3 mg/kg/day of prednisone equivalent for \>3 weeks in the past 60 days * Uncontrolled viral (hepatitis,herpes, zona, varicella) or systemic fungal infection * Immunosuppression pre-existing to hospitalisation (severe lymphopenia \< 500 lymphocytes/mm3, hematologic cancer, aplasia, chemotherapy/radiotherapy for cancer within 3 months prior to the inclusion, or anti-graft rejection drug). * Uncontrolled psychotic disorder (acute or chronical) * Patients not expected to survive for more 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 implementation would alter the HAP-DEX 6-month follow-up, notably the collection of the primary outcome. * Situations that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study
Contact & Investigator
Antoine ROQUILLY
PRINCIPAL INVESTIGATOR
Nantes University Hospital
Frequently Asked Questions
Who can join the NCT06269900 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Hospital Acquired Pneumonia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06269900 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 450 participants.
Is NCT06269900 currently recruiting?
Yes, NCT06269900 is actively recruiting participants. Contact the research team at antoine.roquilly@chu-nantes.fr for enrollment information.
Where is the NCT06269900 trial being conducted?
This trial is being conducted at Amiens, France, Angers, France, Bordeaux, France, Bordeaux, France and 11 additional locations.
Who is sponsoring the NCT06269900 clinical trial?
NCT06269900 is sponsored by Nantes University Hospital. The principal investigator is Antoine ROQUILLY at Nantes University Hospital. The trial plans to enroll 450 participants.