Not Authorised Therapeutic use (Phase IV) Severe acute infection

Individualized Multiplex Pathophysiological Treatment of Severe Acute Infections (IMPACT)

EU CTIS ID: 2025-522215-42-00

What this study is testing

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.

  • 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
  • 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

You likely can't join if

  • 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
See the full eligibility criteria
Who can join
  • 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
What rules you out
  • 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

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.