Safety, Tolerability, Efficacy & Pharmacodynamics of CAL02 in Severe

Status Completed

Clinical Trial Summary

The objectives of this study are to assess the safety, tolerability, clinical and microbiological efficacy and pharmacodynamics of patients who have severe pneumonia caused by Streptococcus pneumoniae after the intravenous administration of CAL02 in addition of standard of care antibiotic treatment.

Clinical Trial Description

Streptococcus pneumoniae is the most frequently identified pathogen of community-acquired bacterial pneumonia and its severe forms are associated with high morbidity and mortality, despite pneumococcal vaccines and medical treatment (antibiotic therapy, alone or in combination). Bacterial toxins, such as the pore-forming toxin (PFT) pneumolysin (from Streptococcus pneumoniae), are involved in the development of invasive disease and play a key role in severe and fatal complications. CAL02 offers a novel therapeutic approach by neutralising bacterial toxins, such as pneumolysin, which recognise specific microdomains on host cell membranes, called lipid rafts. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02583373
Study type	Interventional
Source	Combioxin SA
Contact
Status	Completed
Phase	Phase 1
Start date	March 21, 2016
Completion date	February 20, 2018

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Safety, Tolerability, Efficacy and Pharmacodynamics of CAL02 in Severe Pneumonia Caused by Streptococcus Pneumoniae

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms