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Iloprost and Eptifibatide in Severe Pneumonia with Sepsis
NCT01532544Phase 2
Key facts
- Status
- Terminated
- Start
- Jun 2012
- Primary completion
- Mar 2014
- Countries
- 2
- Sponsor
- Thrombologic
- Modality
- Peptides, Orthosteric Ligands
- Drugs
- iloprosteptifibatide
- Conditions
- sepsisbacterial pneumonia
01
Overview
Phase 2, randomised, double-blind trial of iloprost and eptifibatide in sepsis and bacterial pneumonia (2 arms), sponsored by Thrombologic. Primary endpoint: Change in platelet count from baseline to 72 hours post treatment. Started Jun 2012; status: terminated.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Integrilin and Ilomedin
Continuous infusion of Iloprost and Eptifibatide.
Standard LMWH
Standard treatment daily doses of low molecular weight heparin.
03
Who it enrols
Adult patients with suspected or proven bacterial pneumonia and severe sepsis (2+ SIRS criteria and at least one organ failure beyond respiratory). Excludes patients >125kg, pregnant/breastfeeding, high bleeding risk, recent surgery, or those requiring therapeutic antithrombotics.
04
Endpoints
Primary
Change in platelet count from baseline to 72 hours post treatment
Secondary
Severe bleeding (intracranial or clinical bleeding with the use of 3 RBC units or more)
Days of vasopressor, ventilator and renal replacement therapy and use of blood product
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