HYDROCORTISONE for Severe acute infection

Inclusion criteria

• {"criterion_text":"- Age ≥18 years\n- Suspected acute infection within 72 hours of admission, defined as (1) having samples collected for microbiological evaluation and/or (2) being initiated on antibiotic therapy\n- Admitted to the hospital with an expected duration greater than 24 hours\n- Sequential organ failure assessment (SOFA) ≥2\n- Documented clinical suspicion of infection"}

Exclusion criteria

• {"criterion_text":"- Informed consent following inclusion expected to be unobtainable\n- Inability to read and understand Danish to a degree that allows valid informed consent and completion of trial assessments\n- Pregnant or breastfeeding patients\n- Involuntary admission under the Psychiatric Law\n- Admitted to hospital or undergone surgery during the 14 days prior to admission\n- Expected initiation of palliative care within 48 hours of randomization\n- Previous randomization into the current trial\n- Admitted to ICU or expected transfer to ICU within 2 hours\n- Any condition deemed by the investigator to compromise patient safety or trial integrity including, but not limited to: severe coagulopathy, uncontrolled active bleeding, diabetic ketoacidosis\n- Previous severe anaphylaxis"}

Primary endpoints

• {"endpoint_text":"- Days alive and out of hospital at 14 days post-randomization (DAOH-14)","definition_or_measurement_approach":"Measured as days alive and out of hospital at 14 days post-randomization (DAOH-14)."}

Secondary endpoints

• {"endpoint_text":"- Number of participants with one or more serious adverse event within 14 days of randomization\n- Days alive and out of hospital at 30 days post-randomization\n- All-cause mortality at 14, 30 and 180 days after inclusion\n- ICU admission within 14 and 30 days of randomization\n- Hospital length of stay within 14 and 30 days of admission\n- Health related quality-of-life at 180 days post-randomization (EQ-5D-5L)\n- Duration of antibiotic therapy within 14 and 30 days of randomization\n- Escalation of antibiotic therapy within 14 and 30 days of randomization\n- Days requiring high-flow nasal oxygen therapy, continuous positive airway pressure or non-invasive ventilation within 30 days of randomization\n- Endotracheal intubation for hypoxia within 30 days of randomization\n- Initiation of vasoactive medication within 30 days of randomization\n- Number of participants with elevation of any parameter of liver dysfunction within 30 days of randomization\n- Blood transfusion within 30 days of randomization\n- Hemoglobin <6.2 within 30 days of randomization","definition_or_measurement_approach":"Each endpoint measured within the timeframe stated in the endpoint description (e.g., SAEs within 14 days post-randomization; mortality at 14, 30 and 180 days; EQ-5D-5L at 180 days; organ-support and therapy escalation outcomes within specified days)."}

Denmark

Earliest CTIS Part Ii Submission Date

31-10-2025

Latest Decision Or Authorization Date

08-12-2025

Processing Time Days

38

Number Of Sites

1

Number Of Participants

300

Primary sponsor

Full Name

Copenhagen University Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Region Hovedstaden","duties_or_roles":"","organisation_type":"Hospital/Clinic/Other health care facility"}