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

This study has suspended participant recruitment.
Sponsor:
Collaborators:
Anders Perner
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Thrombologic ApS
ClinicalTrials.gov Identifier:
NCT01532544
First received: January 30, 2012
Last updated: September 4, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Pneumonia
Drug: Ilomedin and Integrilin
Drug: low molecular weight heparin.
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Thrombologic ApS:

Primary Outcome Measures:
  • Change in platelet count from baseline to 72 hours post treatment [ Time Frame: 11 bloodsamples over 7 days ] [ Designated as safety issue: Yes ]
    Will be from pre-study drug administration until 7 days


Secondary Outcome Measures:
  • Severe bleeding (intracranial or clinical bleeding with the use of 3 RBC units or more) (KyperSept trial) [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Followed longer if not discharged from the ICU at day 7


Estimated Enrollment: 36
Study Start Date: June 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Integrilin and Ilomedin given as continous infusion Drug: Ilomedin and Integrilin
Continuous infusion
Other Name: Integrilin and Ilomedin
Placebo Comparator: Standard treatment daily doses of low molecular weight heparin
Standard treatment daily doses of low molecular weight heparin.
Drug: low molecular weight heparin.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01532544

Locations
Denmark
University hospital Copenhagen
Copenhagen, Denmark, 2100
Vejle hospital
Vejle, Denmark
Finland
Kuopio University Hospital
Kuopio, Finland
Tampere University Hospital
Tampere, Finland, 33521
Sponsors and Collaborators
Thrombologic ApS
Anders Perner
Rigshospitalet, Denmark
  More Information

No publications provided

Responsible Party: Thrombologic ApS
ClinicalTrials.gov Identifier: NCT01532544     History of Changes
Other Study ID Numbers: THR-PS-03, 2011-002254-31
Study First Received: January 30, 2012
Last Updated: September 4, 2013
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Finland: Data Protection Board
Finland: Ethics Committee
Finland: Finnish Medicines Agency

Keywords provided by Thrombologic ApS:
Severe pneumonia

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Calcium heparin
Heparin
Heparin, Low-Molecular-Weight
Dalteparin
Eptifibatide
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on October 01, 2014