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

NCT01532544 | Terminated Phase 2 DMC

• 2 other identifiers: THR-PS-032011-002254-31
• Study Type: interventional
• Target: 5
• Locations: 2 countries
• Sites: 4

Brief Summary

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.

Conditions

Pneumonia

Keywords

Severe pneumonia

Outcome Measures

Primary Outcomes (1)

• Change in platelet count from baseline to 72 hours post treatment

  Will be from pre-study drug administration until 7 days

  11 bloodsamples over 7 days

Secondary Outcomes (2)

• Severe bleeding (intracranial or clinical bleeding with the use of 3 RBC units or more) (KyperSept trial)

  7 days

• Days of vasopressor, ventilator and renal replacement therapy and use of blood product (in ICU) after randomization

  7 days

Study Arms (2)

Integrilin and Ilomedin given as continous infusion

EXPERIMENTAL

Drug: Ilomedin and Integrilin

Standard treatment daily doses of low molecular weight heparin

PLACEBO COMPARATOR

Standard treatment daily doses of low molecular weight heparin.

Drug: low molecular weight heparin.

Interventions

Ilomedin and Integrilin DRUG

Continuous infusion

Also known as: Integrilin and Ilomedin

Integrilin and Ilomedin given as continous infusion

low molecular weight heparin. DRUG

Standard treatment daily doses of low molecular weight heparin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age AND
• 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.
• Dyspnea and/or tachypnea (\>20 breaths/minute) or mechanical ventilation
• 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
• 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
• Can be randomized into trial and dosed \< 48 h after severe sepsis diagnosis AND
• Consent is obtainable -

You may not qualify if:

• Patient is pregnant or breast-feeding
• Patient weigh more than 125 kg
• Patients with known allergy towards any of the investigational products or contraindications which should be excluded according to the investigational product specifications
• Investigators clinical decision deeming study participation not favourable for the patient
• Patients in whom the clinician finds antithrombotic therapy contraindicated - prophylaxis included
• 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.
• 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.

Sponsors & Collaborators

• Thrombologic ApS: lead
• Anders Perner: collaborator
• Rigshospitalet, Denmark: collaborator

Study Sites (4)

University hospital Copenhagen

Copenhagen, 2100, Denmark

Location

Vejle hospital

Vejle, Denmark

Location

Kuopio University Hospital

Kuopio, Finland

Location

Tampere University Hospital

Tampere, 33521, Finland

Location

MeSH Terms

Conditions

Pneumonia

Interventions

Eptifibatide; Heparin, Low-Molecular-Weight

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Peptides; Amino Acids, Peptides, and Proteins; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2012
• First Posted: February 14, 2012
• Study Start: June 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: April 22, 2016

Record last verified: 2016-04

Locations

FI (2); DK (2)