Efficacy and Safety of 72-hour Infusion of Prostacyclin (1 ng/kg/Min) in Mechanically Ventilated Patients With Infectious Pulmonary Endotheliopathy - a Multicenter Randomized, Placebo-controlled, Blinded, Investigator-initiated Trial

COMBAT-ARF

The purpose of this clinical trial is to investigate the efficacy and safety of continuous intravenous administration of low dose iloprost versus placebo for 72-hours, in 450 mechanically ventilated patients with infectious respiratory failure. The study hypothesis is that iloprost may be beneficial as an endothelial rescue treatment as it is anticipated to deactivate the endothelium and restore vascular integrity in patients suffering from respiratory failure caused by endothelial breakdown, ultimately improving survival.

2024-04-15

2026-12-30

2026-12-30

Recruiting

Early phase I

450

Inclusion Criteria: * Adult intensive care patients (age ≥ 18 years) * Suspected pulmonary infection * Need for mechanical ventilation (\< 24 hours from time of screening) * soluble thrombomodulin (sTM) ≥ 4 ng/mL in blood plasma Exclusion Criteria: * Withdrawal from active therapy * Pregnancy (non-pregnancy confirmed by patient having a negative urine- or plasma Choriogonadotropin (hCG) or being postmenopausal defined as females at 60 years old or beyond or at the investigators discretion) * Septic shock according to the Sepsis 3 criteria AND a sTM\> 10 ng/ml * Known hypersensitivity to iloprost or to any of the other ingredients. * Previously included in this trial or a prostacyclin trial within 30 days * Life-threatening bleeding defined by the treating physician * Known severe heart failure (NYHA class IV) * Suspected acute coronary syndrome

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomization active/placebo (1:1) parallel arms', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) The preparation will be done by an unblinded study nurse independent of the including ICU´s, who will be responsible for preparing the investigational drug to be administered in a blinded fashion. Iloprost is a colorless fluid that is to be diluted in 0.9% saline. The infusion pump containing diluted active drug and placebo will be identical in both looks and behavior.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 450, 'type': 'ESTIMATED'}}

2024-05-07