Authorised Therapeutic exploratory (Phase II) Infectious pulmonary endotheliopathy

COMBAT-ARF

EU CTIS ID: 2024-512641-16-00

What this study is testing

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.

  • Therapeutic exploratory (Phase II)

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

  • Adult intensive care patients (aged 18 years or above)
  • Suspected pulmonary infection
  • Need for high-flow (min. 20 l/min) oxygen therapy with a minimum FiO2 of 50% or need for mechanical ventilation (< 24hours from time of screening)
  • Endothelial biomarker (sTM) ≥ 4 ng/mL

You likely can't join if

  • Withdrawal from active therapy
  • Septic shock according to Sepsis-3 AND 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)
See the full eligibility criteria
Who can join
  • Adult intensive care patients (aged 18 years or above)
  • Suspected pulmonary infection
  • Need for high-flow (min. 20 l/min) oxygen therapy with a minimum FiO2 of 50% or need for mechanical ventilation (< 24hours from time of screening)
  • Endothelial biomarker (sTM) ≥ 4 ng/mL
What rules you out
  • Withdrawal from active therapy
  • Septic shock according to Sepsis-3 AND 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
  • Pregnancy (non-pregnancy confirmed by patient being postmenopausal (age 60 or above) or having a negative urine- or plasma-hCG)

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, 18-64 years, 65+ 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.