Integrilin and Ilomedin in Combination in Comparison to Standard Treatment in Severe Pneumonia Patients With Severe Sepsis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01532544
Recruitment Status : Terminated (Difficulty recruiting patients, company closed down)
First Posted : February 14, 2012
Last Update Posted : April 22, 2016
Anders Perner
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Thrombologic ApS

January 30, 2012
February 14, 2012
April 22, 2016
June 2012
March 2014   (Final data collection date for primary outcome measure)
Change in platelet count from baseline to 72 hours post treatment [ Time Frame: 11 bloodsamples over 7 days ]
Will be from pre-study drug administration until 7 days
Same as current
Complete list of historical versions of study NCT01532544 on Archive Site
  • Severe bleeding (intracranial or clinical bleeding with the use of 3 RBC units or more) (KyperSept trial) [ Time Frame: 7 days ]
    If longer in the ICU ward followed until discharged.
  • Days of vasopressor, ventilator and renal replacement therapy and use of blood product (in ICU) after randomization [ Time Frame: 7 days ]
    Followed longer if not discharged from the ICU at day 7
Same as current
Not Provided
Not Provided
Integrilin and Ilomedin in Combination in Comparison to Standard Treatment in Severe Pneumonia Patients With Severe Sepsis
Double-blinded, Randomized Trial in Severe Pneumonia Patients With Severe Sepsis Investigating the Safety and Efficacy of Co-administration of Iloprost and Ascending Doses of Eptifibatide Compared to Low-molecular-weight Heparin
This is an investigator sponsored double-blinded, multinational, multi center, randomized (2:1 active:placebo), placebo-controlled, phase IIa trial in severe pneumonia patients with severe sepsis or septic shock, investigating the safety and efficacy of co-administration of Iloprost and escalating doses of Eptifibatide for continuous intravenous infusion in totally 36 patients.
Not Provided
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Drug: Ilomedin and Integrilin
    Continuous infusion
    Other Name: Integrilin and Ilomedin
  • Drug: low molecular weight heparin.
  • Experimental: Integrilin and Ilomedin given as continous infusion
    Intervention: Drug: Ilomedin and Integrilin
  • Placebo Comparator: Standard treatment daily doses of low molecular weight heparin
    Standard treatment daily doses of low molecular weight heparin.
    Intervention: Drug: low molecular weight heparin.
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
March 2014
March 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. At least 18 years of age AND
  2. Suspected or proven bacterial pneumonia requiring administration of antibiotics:

    • Clinical diagnosis of pneumonia, (i.e. new or increased cough, production of purulent sputum or a change in the character of sputum in subjects who normally have purulent sputum, typical auscultatory findings of pneumonia on chest examination) and:
    • chest radiograph or CT within the last 24 hr showing a pulmonary infiltrate.
  3. Dyspnea and/or tachypnea (>20 breaths/minute) or mechanical ventilation
  4. Two or more systemic inflammatory response syndrome (SIRS) criteria within the last 24 hours:

    • Temperature </= 36˚ C or >/= 38˚C
    • Heart rate >/= 90 beats per minute
    • Mechanical ventilation for acute respiratory process or respiratory rate >/= 20 breaths per minute or PaC02 < 4.2 kPa
    • WBC >/= 12,000/mm³ OR </= 4,000/mm³ OR > 10% bands
  5. At least one organ failure beyond respiratory failure (cerebral, cardiovascular, hepatic, renal or coagulation within the last 24 hours (> 2 in SOFA score for the specific organ system) AND
  6. Can be randomized into trial and dosed < 48 h after severe sepsis diagnosis AND
  7. Consent is obtainable -

Exclusion Criteria:

  1. Patient is pregnant or breast-feeding
  2. Patient weigh more than 125 kg
  3. Patients with known allergy towards any of the investigational products or contraindications which should be excluded according to the investigational product specifications
  4. Investigators clinical decision deeming study participation not favourable for the patient
  5. Patients in whom the clinician finds antithrombotic therapy contraindicated - prophylaxis included
  6. Patients at increased risk of bleeding: Surgery in the previous 12 h, expected surgery within 72 h, epidural or spinal puncture in the previous 12 h, platelet count less than 30,000/mm3 in the previous 24 h, INR above 2.0 in the previous 24 h, need of blood products for bleeding in the previous 24 h, treatment with any antithrombotics within 12 h (profylaxis excepted), current or previous intracranial bleeding or traumatic brain or spinal injury within the last month.
  7. Patients requiring any form of antithrombotics (beyond profylaxis) in therapeutic doses or prothrombotics in any dose, including,

    • unfractionated heparin within 8 hours before the infusion (prophylactic heparin up to 15,000 U/day permitted).
    • Low-molecular-weight heparin within 12 hours (prophylactic doses permitted).
    • exceeded the upper limit of normal.
    • Acetylsalicylic acid more than 650 mg/day within 3 days before the study.
    • Thrombolytic therapy within 3 days before the study (catheter clearance doses permitted).
    • Glycoprotein IIb-IIIa antagonists within 7 days before the study.
    • Antithrombin III with dose greater than 10,000 U within 12 hours before the study.
    • Protein C within 24 hours of the study.
  8. Previous diagnosed condition that might mimic or complicate the course and evaluation of the infectious disease process (severe bronchiectasis, lung abcess or empyema, aspiration pneumonia, active tuberculosis, pulmonary malignancy, cystic fibrosis, severe chronic interstitial pneumonia, COPD or other forms of chronic lung disease requiring home oxygen treatment or resulting in chronic CO2 retention, , etc.)
  9. Patient not expected to survive more than 30 days because of uncorrectable medical or surgical condition other than sepsis
  10. Patient with acute or chronic renal failure requiring dialysis (renal failure without need for dialysis permitted).
  11. Patient with hematological malignancies of any kind
  12. Patients who have undergone transplantation of bone marrow, liver, pancreas, heart, lung, or bowel (kidney transplant permitted)
  13. Patient has known hypercoagulable condition:

    APC resistance Hereditary protein C, protein S, or antithrombin III deficiency Anticardiolipin or antiphospholipid antibody Lupus anticoagulant Homocysteinemia Recent or highly suspected pulmonary embolism or deep venous thrombosis (within 3 months)

  14. Patients with known congenital hypocoagulable diseases
  15. Patient with known AIDS
  16. Patient with known primary pulmonary hypertension
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Denmark,   Finland
2011-002254-31 ( EudraCT Number )
Not Provided
Plan to Share IPD: Undecided
Thrombologic ApS
Thrombologic ApS
  • Anders Perner
  • Rigshospitalet, Denmark
Not Provided
Thrombologic ApS
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP