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Clinical Trials/2025-522215-42-00
2025-522215-42-00
Withdrawn
Phase 4

Individualized Multiplex Pathophysiological Treatment of Severe Acute Infections (IMPACT)

Copenhagen University Hospital1 site in 1 country300 target enrollmentStarted: December 8, 2025Last updated:
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Overview

Phase
Phase 4
Status
Withdrawn
Enrollment
300
Locations
1
Primary Endpoint
Days alive and out of hospital at 14 days post-randomization (DAOH-14)
OverviewEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

The primary objective of this trial is to determine if an individualized treatment strategy for patients with severe acute infections can reduce mortality and hospital length of stay.

Eligibility Criteria

Ages
18 years to 65+ years (65+ Years, 18-64 Years)
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Age ≥18 years
  • •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
  • •Admitted to the hospital with an expected duration greater than 24 hours
  • •Sequential organ failure assessment (SOFA) ≥2
  • •Documented clinical suspicion of infection

Exclusion Criteria

  • •Informed consent following inclusion expected to be unobtainable
  • •Inability to read and understand Danish to a degree that allows valid informed consent and completion of trial assessments
  • •Pregnant or breastfeeding patients
  • •Involuntary admission under the Psychiatric Law
  • •Admitted to hospital or undergone surgery during the 14 days prior to admission
  • •Expected initiation of palliative care within 48 hours of randomization
  • •Previous randomization into the current trial
  • •Admitted to ICU or expected transfer to ICU within 2 hours
  • •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
  • •Previous severe anaphylaxis

Outcomes

Primary Outcomes

Days alive and out of hospital at 14 days post-randomization (DAOH-14)

Days alive and out of hospital at 14 days post-randomization (DAOH-14)

Secondary Outcomes

  • Number of participants with one or more serious adverse event within 14 days of randomization
  • Duration of antibiotic therapy within 14 and 30 days of randomization
  • Escalation of antibiotic therapy within 14 and 30 days of randomization
  • Days requiring high-flow nasal oxygen therapy, continuous positive airway pressure or non-invasive ventilation within 30 days of randomization
  • Endotracheal intubation for hypoxia within 30 days of randomization
  • Initiation of vasoactive medication within 30 days of randomization
  • Number of participants with elevation of any parameter of liver dysfunction within 30 days of randomization
  • Blood transfusion within 30 days of randomization
  • Hemoglobin <6.2 within 30 days of randomization
  • Days alive and out of hospital at 30 days post-randomization
  • All-cause mortality at 14, 30 and 180 days after inclusion
  • ICU admission within 14 and 30 days of randomization
  • Hospital length of stay within 14 and 30 days of admission
  • Health related quality-of-life at 180 days post-randomization (EQ-5D-5L)

Investigators

Sponsor Class
Hospital/Clinic/Other health care facility
Responsible Party
Principal Investigator
Principal Investigator

Theis Skovsgaard Itenov

Scientific

Copenhagen University Hospital

Study Sites (1)

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