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New treatment option for Hospital Acquired Pneumonia
Official title Dexamethasone for Treating Severe Hospital-acquired Pneumonia in Critically Ill Patients With a Proinflammatory Phenotype
ClinicalTrials.gov ID: NCT06269900
What this study is testing
What is Dexamethasone?
Dexamethasone is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hospital acquired pneumonia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- Hospital-acquired pneumonia (HAP) according to European guidelines (Torres et al. Eur Respir J 2017): Association of two criteria among (body...
- 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...
You likely can't join if
- 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
See the full eligibility 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...
- 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...
- 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.
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
- Angers, France
- Bordeaux, France
- Brest, France
- Caen, France
- Clermont-Ferrand, France
- Clichy, France
- Garches, France
- Grenoble, France
- Limoges, France
- Marseille, France
- Nancy, France
- Nantes, France
- Nîmes, France
- Paris, France
- Poitiers, France
- Rennes, France
- Strasbourg, France
- Toulouse, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, France; Angers, France; Bordeaux, France; Brest, France; Caen, France; Clermont-Ferrand, France and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.