Efficacy and safety of 72-hour infusion of Prostacyclin (1 ng/kg/min) in mechanically ventilated patients with infectious respiratory failure

Efficacy and safety of 72-hour infusion of Prostacyclin (1 ng/kg/min) in mechanically ventilated patients with infectious pulmonary endotheliopathy – a multicentre randomized, placebo-controlled, blinded, investigator-initiated trial - COMBAT-ARF

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-004079-17-DK

Enrollment

450

Registered

2023-02-02

Start date

2023-03-20

Completion date

Unknown

Last updated

2024-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infectious pulmonary endotheliopathy MedDRA version: 20.0 Level: LLT Classification code 10038696 Term: Respiratory failure (excl neonatal) System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Trade Name: Ilomedin Product Name: Ilomedin Pharmaceutical Form: Concentrate and solvent for concentrate for solution for infusion INN or Proposed INN: Iloprost CAS Number: 78919-13-8 Concentration un

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adult intensive care patients (age = 18 years) 2. Suspected pulmonary infection 3. Need for mechanical ventilation (=65 years) yes F.1.3.1 Number of subjects for this age range 300

Exclusion criteria

Exclusion criteria: 1. Withdrawal from active therapy 2. Pregnancy 3. Septic shock according to Sepsis-3 AND sTM>10 ng/ml 4. Known hypersensitivity to iloprost or to any of the other ingredients. 5. Previously included in this trial or a prostacyclin trial within 30 days 6. Life-threatening bleeding defined by the treating physician 7. Known severe heart failure (NYHA class IV) 8. Suspected acute coronary syndrome

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to investigate whether continuous infusion of iloprost at a dose of 1 ng/kg/min for 72-hours reduces the 28-day mortality as compared to placebo.;Secondary Objective: Not applicable;Primary end point(s): 28-day all cause mortality;Timepoint(s) of evaluation of this end point: Day 28	—

Secondary

Measure	Time frame
Secondary end point(s): 90-day all cause mortality Days alive and vasopressor-free days in the ICU within 28 and 90 days Days alive and renal replacement free days in the ICU within 28 and 90 days Days alive without mechanical ventilation in the ICU within 28 and 90 days Total number and numbers of patient with one or more serious adverse reactions within the first 7 days Total numbers and numbers of patients with one or more serious adverse events within the first 7 days ;Timepoint(s) of evaluation of this end point: Day 28 and day 90	—

Measure

Time frame

Secondary end point(s): 90-day all cause mortality Days alive and vasopressor-free days in the ICU within 28 and 90 days Days alive and renal replacement free days in the ICU within 28 and 90 days Days alive without mechanical ventilation in the ICU within 28 and 90 days Total number and numbers of patient with one or more serious adverse reactions within the first 7 days Total numbers and numbers of patients with one or more serious adverse events within the first 7 days ;Timepoint(s) of evaluation of this end point: Day 28 and day 90

—

Countries

Denmark

Contacts

Public ContactKristine Pedersen

Rigshospitalet, Section of Transfusion Medicine, Capital Blood Bank 2034

kristine.holst.pedersen.01@regionh.dk4535453489

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026