Nangibotide in patients with septic shock: a Phase 2a randomized controlled clinical trial

Purpose Nangibotide is a specific TREM-1 inhibitor that tempered deleterious host–pathogens interactions, restored vascular function, and improved survival, in animal septic shock models. This study evaluated the safety and pharmacokinetics of nangibotide and its effects on clinical and pharmacodyna...

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Bibliographic Details
Published in:Intensive care medicine 2020-07, Vol.46 (7), p.1425-1437
Main Authors: François, Bruno, Wittebole, Xavier, Ferrer, Ricard, Mira, Jean-Paul, Dugernier, Thierry, Gibot, Sébastien, Derive, Marc, Olivier, Aurélie, Cuvier, Valérie, Witte, Stephan, Pickkers, Peter, Vandenhende, François, Garaud, Jean-Jacques, Sánchez, Miguel, Salcedo-Magguilli, Margarita, Laterre, Pierre-François
Format: Article
Language:English
Subjects:
Anesthesiology
Animal models
Animals
Antibodies
Biological products
Biomarkers
Clinical trials
Critical Care Medicine
Double-Blind Method
Drug dosages
Emergency Medicine
Health aspects
Humans
Immunologic Factors
Intensive
Intensive care
Medicine
Medicine & Public Health
Original
Pain Medicine
Patients
Pediatrics
Pharmacodynamics
Pharmacokinetics
Pharmacology
Pneumology/Respiratory System
Randomization
Safety
Sepsis
Septic shock
Shock, Septic - drug therapy
Treatment Outcome
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Summary:Purpose Nangibotide is a specific TREM-1 inhibitor that tempered deleterious host–pathogens interactions, restored vascular function, and improved survival, in animal septic shock models. This study evaluated the safety and pharmacokinetics of nangibotide and its effects on clinical and pharmacodynamic parameters in septic shock patients. Methods This was a multicenter randomized, double-blind, two-stage study. Patients received either continuous infusion of nangibotide (0.3, 1.0, or 3.0 mg/kg/h) or placebo. Treatment began 
ISSN:0342-4642
1432-1238
DOI:10.1007/s00134-020-06109-z