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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 - the HAP-DEX study
EU CTIS ID: 2023-508153-12-00
What this study is testing
The primary objective of this randomized trial is to determine the efficacy of dexamethasone plus standard of care (SOC) as compared to placebo plus SOC for the treatment of severe hospital-acquired pneumonia in patients with a pro-inflammatory profile.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult patients (18yr to 85yr)
- 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.
You likely can't join if
- Pregnant women (serum or urine test), breastfeeding women.
- Uncontrolled psychotic disorder (acute or chronical)
- Patients not expected to survive for more than 48 hours
- Severe septic shock (norepinephrine > 0.4 microg/kg/min and serum lactate level greater than 2 mmol/L) at the time of randomisation
- Patient under legal protection (incl. under guardianship or trusteeship).
- Hypersensitivity to dexamethasone and hypersensitivity to all of its excipients
See the full eligibility criteria
- Adult patients (18yr to 85yr)
- 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: sexual abstinence, use of a condom with spermicide, contraceptive sponge, uterine diaphragm, hormonal contraception, or intrauterine contraceptive device
- Pregnant women (serum or urine test), breastfeeding women.
- Uncontrolled psychotic disorder (acute or chronical)
- Patients not expected to survive for more than 48 hours
- Severe septic shock (norepinephrine > 0.4 microg/kg/min and serum lactate level greater than 2 mmol/L) at the time of randomisation
- 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.
- 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, zona,herpes, 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).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.