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Efficacy of DEXamethasone in Patients With Acute Hypoxemic REspiratory Failure Caused by INfEctions (DEXA-REFINE)
EU CTIS ID: 2024-519759-27-00
What this study is testing
The effects 20/10 mg vs. 6 mg of intravenous dexamethasone on the number of deaths at 60 days after randomization and the number of days alive without ventilator support at 28 days, and other subjectcentered outcomes in adult subjects with AHRF (including ARDS) caused by pulmonary or systemic infections (including COVID-19). Death from any cause 60 days after randomization. Death, if occurred, will be recorded irrespective whether the subject remains in the same hospital, in another health care facility, or discharged home. If subjects are discharged alive from hospital before day 60, clinical status information at 60 days will be obtained from the electronic clinical record.
- Therapeutic use (Phase IV)
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
- Age ≥18 years.
- Intubated and mechanically ventilated, defined as requiring ventilatory support at the time of Screening.
- Acute onset of AHRF (as defined by a PaO2/FiO2 ≤300 mmHg during at least 6 hours from diagnosis. For the measurement of PaO2 and calculation of PaO2/FiO2 ratio, the minimum accepted value for PEEP is 5 cmH2O and for FiO2 is 0.3. ARDS is defined by Berlin criteria,4 which includes: (i) having pneumonia or worsening respiratory symptoms, (ii) bilateral pulmonary infiltrates on chest imaging (x-ray or CT scan), (iii) absence of left atrial hypertension or no clinical signs of left heart failure, and (iv) hypoxemia, as defined by a PaO2/FiO2 ≤300 mmHg on positive end-expiratory pressure (PEEP) of ≥5 cmH2O, regardless of FiO2.
- Pulmonary or systemic infectious etiology of AHRF.
You likely can't join if
- Subjects with a known contraindication to corticosteroids or know hypersensitivity. History of any hypersensitivity reaction to dexamethasone, including but not limited to urticaria, eczema, angioedema, bronchospasm, and anaphylaxis.
- Subjects who have an indication of chronic use of higher doses of systemic corticosteroids. Use of systemic corticosteroids in doses higher than 6 mg dexamethasone equivalents for other indications than COVID- 19: systemic corticosteroids in doses higher than 6 mg dexamethasone / 6 mg betamethasone / 200 mg cortisone / 160 mg hydrocortisone / 32 mg methylprednisolone / 40 mg prednisolone / 40 mg prednisone.
- Subjects who have received corticosteroids for 5 consecutive days or more up to the day of screening.
- Pregnant woman.
- Participation in another therapeutic trial study that collide.
- Lack of informed consent.
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, 18-64 years, 65+ 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.