NCT02583373

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

Randomised, Multicentre, Double-blind, Placebo-controlled Study to Assess the Safety, Efficacy and Pharmacodynamics After the Intravenous Administration of CAL02 in Severe Community-acquired Pneumonia Due to Streptococcus Pneumoniae

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Combioxin SA · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Pneumonia
• Pneumococcal Infections

Interventions

Type	Name	Description
DRUG	CAL02 Low-dose	Two doses of CAL02 (low-dose) administered 2 times (24 hours apart) as i.v. infusion
DRUG	CAL02 High-dose	Two doses of CAL02 (high-dose) administered 2 times (24 hours apart) as i.v. infusion
DRUG	Placebo	Placebo administered administered 2 times (24 hours apart) as i.v. infusion

Timeline

• Start date: 2016-03-21
• Primary completion: 2018-02-20
• Completion: 2018-02-20
• First posted: 2015-10-22
• Last updated: 2020-01-27

Locations

10 sites across 2 countries: Belgium, France