Clinical trial • Phase IV • Respiratory | Infectious Disease

ILOPROST TROMETAMOL for Infectious pulmonary endotheliopathy | Respiratory failure

Phase IV trial of ILOPROST TROMETAMOL for Infectious pulmonary endotheliopathy | Respiratory failure.

Overview

Trial Therapeutic Area
Respiratory | Infectious Disease
Trial Disease
Infectious pulmonary endotheliopathy | Respiratory failure
Trial Stage
Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
11-03-2024
First CTIS Authorization Date
25-03-2024

Trial design

Randomised, ilomedin (iloprost trometamol) continuous infusion 1 ng/kg/min for 72 hours; comparator/placebo: natriumklorid (sodium chloride) solution for infusion matched to active treatment schedule.-controlled Phase IV trial across 5 sites in Denmark.

Randomised
Yes
Comparator
Ilomedin (iloprost trometamol) continuous infusion 1 ng/kg/min for 72 hours; Comparator/placebo: Natriumklorid (sodium chloride) solution for infusion matched to active treatment schedule.
Target Sample Size
450
Trial Duration For Participant
90

Eligibility

Recruits 450 Critically ill adult intensive care patients are identified as a vulnerable population (isVulnerablePopulationSelected = true). Subject information sheets and informed consent forms are provided for patients, relatives and legal guardians (multiple ICF and SIS documents listed), indicating that consent may be obtained from legal guardians/relatives when the patient is unable to provide consent..

Pregnancy Exclusion
Pregnancy (non-pregnancy confirmed by patient being postmenopausal (age 60 or above) or having a negative urine- or plasma-hCG)
Vulnerable Population
Critically ill adult intensive care patients are identified as a vulnerable population (isVulnerablePopulationSelected = true). Subject information sheets and informed consent forms are provided for patients, relatives and legal guardians (multiple ICF and SIS documents listed), indicating that consent may be obtained from legal guardians/relatives when the patient is unable to provide consent.

Inclusion criteria

  • {"criterion_text":"- Adult intensive care patients (aged 18 years or above)\n- Suspected pulmonary infection\n- 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)\n- Endothelial biomarker (sTM) ≥ 4 ng/mL"}

Exclusion criteria

  • {"criterion_text":"- Withdrawal from active therapy\n- Septic shock according to Sepsis-3 AND sTM>10 ng/ml\n- Known hypersensitivity to iloprost or to any of the other ingredients.\n- Previously included in this trial or a prostacyclin trial within 30 days\n- Life-threatening bleeding defined by the treating physician\n- Known severe heart failure (NYHA class IV)\n- Suspected acute coronary syndrome\n- Pregnancy (non-pregnancy confirmed by patient being postmenopausal (age 60 or above) or having a negative urine- or plasma-hCG)"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 28-day all cause mortality","definition_or_measurement_approach":"All-cause mortality assessed at 28 days (death from any cause within 28 days); primary objective compares 28-day mortality between iloprost infusion and placebo."}

Secondary endpoints

  • {"endpoint_text":"- 90-day mortality","definition_or_measurement_approach":"All-cause mortality assessed at 90 days."}
  • {"endpoint_text":"- Days alive without vasopressor in the ICU within 28-and 90 days","definition_or_measurement_approach":"Number of days alive and free of vasopressor support while in the ICU within 28- and 90-day windows."}
  • {"endpoint_text":"- Days alive without mechanical ventilation in the ICU within 28 -and 90 days","definition_or_measurement_approach":"Number of days alive and free of invasive mechanical ventilation while in the ICU within 28- and 90-day windows."}
  • {"endpoint_text":"- Days without renal replacement in the ICU within 28-and 90 days","definition_or_measurement_approach":"Number of days alive and free of renal replacement therapy while in the ICU within 28- and 90-day windows."}
  • {"endpoint_text":"- Numbers of serious adverse reactions within the first 7 days","definition_or_measurement_approach":"Count of serious adverse reactions occurring within the first 7 days after randomisation/treatment start."}
  • {"endpoint_text":"- Numbers of serious adverse events within the first 7 days","definition_or_measurement_approach":"Count of serious adverse events occurring within the first 7 days after randomisation/treatment start."}

Recruitment

Planned Sample Size
450
Recruitment Window Months
41
Consent Approach
Informed consent is managed via subject information sheets (SIS) and informed consent forms (ICF). Documents exist for patients, relatives and legal guardians and for biobank consent, indicating provision for consent by legal guardians/relatives when patients are unable to consent. The trial enrolls adults (aged 18 or above).

Geography

Total Number Of Sites
5
Total Number Of Participants
450

Denmark

Earliest CTIS Part Ii Submission Date
18-03-2024
Latest Decision Or Authorization Date
26-01-2026
Processing Time Days
679
Number Of Sites
5
Number Of Participants
450

Sites

Site Name
Region Hovedstaden
Department Name
Intensive care unit
Principal Investigator Name
Niels Erikstrup Clausen
Principal Investigator Email
niels.erikstrup.clausen@regionh.dk
Contact Person Name
Niels Erikstrup Clausen
Site Name
Nordsjaellands Hospital
Department Name
Intensive care unit
Principal Investigator Name
Morten Bestle
Principal Investigator Email
Morten.Bestle@regionh.dk
Contact Person Name
Morten Bestle
Contact Person Email
Morten.Bestle@regionh.dk
Site Name
Region Sjaelland
Department Name
Intensive Care
Principal Investigator Name
Lars Peter Kloster Andersen
Principal Investigator Email
lapan@regionsjaelland.dk
Contact Person Name
Lars Peter Kloster Andersen
Contact Person Email
lapan@regionsjaelland.dk
Site Name
Region Hovedstaden
Department Name
Intensive care unit
Principal Investigator Name
Klaus Tjelle Kristiansen
Principal Investigator Email
klaus.tjelle.kristiansen.02@regionh.dk
Contact Person Name
Klaus Tjelle Kristiansen
Site Name
Region Hovedstaden
Department Name
Intensive care unit
Principal Investigator Name
Peter Soee-Jensen
Principal Investigator Email
peter.soee-jensen@regionh.dk
Contact Person Name
Peter Soee-Jensen
Contact Person Email
peter.soee-jensen@regionh.dk

Sponsor

Primary sponsor

Full Name
Rigshospitalet
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Denmark

Third parties

  • {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"sponsorDuties code 1","organisation_type":"Hospital/Clinic/Other health care facility"}

Investigational products

Investigational Product Name
Ilomedin, koncentrat til infusionsvæske, opløsning
Active Substance
ILOPROST TROMETAMOL
Modality
Small molecule
Routes Of Administration
Concentrate for solution for infusion (for IV infusion)
Route
Intravenous infusion
Authorisation Status
Authorised (marketing authorisation number 19398)
Starting Dose
1 ng/kg/min
Dose Levels
1 ng/kg/min
Frequency
Continuous infusion for 72 hours
Investigational Product Name
Natriumklorid "B. Braun"
Active Substance
SODIUM CHLORIDE
Modality
Small molecule
Routes Of Administration
Solution for infusion (for IV infusion)
Route
Intravenous infusion
Authorisation Status
Authorised (marketing authorisation number 13040)
Frequency
Matched to active treatment schedule (placebo infusion)

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