Individualized Multiplex Pathophysiological Treatment of Severe Acute Infections (IMPACT)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Copenhagen University Hospital

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01], Diseases [C] - Virus Diseases [C02]

Decision date (initial)

2025-12-08

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2025-522215-42-00

WHO UTN

U1111-1322-3072

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy

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.

Conditions and MedDRA coding

Severe acute infection

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

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

Exclusion criteria 10

1. Informed consent following inclusion expected to be unobtainable
2. Pregnant or breastfeeding patients
3. Involuntary admission under the Psychiatric Law
4. Admitted to hospital or undergone surgery during the 14 days prior to admission
5. Expected initiation of palliative care within 48 hours of randomization
6. Previous randomization into the current trial
7. Admitted to ICU or expected transfer to ICU within 2 hours
8. 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
9. Previous severe anaphylaxis
10. Inability to read and understand Danish to a degree that allows valid informed consent and completion of trial assessments

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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

Secondary endpoints 14

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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Copenhagen University Hospital

Sponsor organisation

Copenhagen University Hospital

Address

Bispebjerg Bakke 23

City

Copenhagen Nv

Postcode

2400

Country

Denmark

Scientific contact point

Organisation

Copenhagen University Hospital

Contact name

Theis Skovsgaard Itenov

Public contact point

Organisation

Copenhagen University Hospital

Contact name

Theis Skovsgaard Itenov

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 13 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications