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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Randomised, Multicentre, Double-blind, Placebo-controlled Study to Assess the Safety, Efficacy and Pharmacodynamics After the Intravenous Administration of CAL02 in Severe Community-acquired

Brief 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 Summary: 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.
Sponsor: Combioxin SA

Current Primary Outcome: Frequency, severity and characteristics of adverse events after two iv. administrations of CAL02. [ Time Frame: 29 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Clinical efficacy: cure. [ Time Frame: 29 days. ]
  Complete resolution of signs and symptoms of pneumonia
• Pharmacodynamic effects. [ Time Frame: 29 days. ]
  Measuring biomarkers (CRP/PCT).
• Microbiological efficacy. [ Time Frame: 29 days. ]
  Eradication: baseline isolate not present in repeat culture from original infection site
• Survival. [ Time Frame: 29 days ]
  Assessment of 28 days all cause mortality.

Original Secondary Outcome:

• Clinical efficacy: cure. [ Time Frame: 29 days. ]
  Assessment of clinical outcome.
• Pharmacodynamic effects. [ Time Frame: 29 days. ]
  Measuring biomarkers (CRP/PCT).
• Microbiological efficacy. [ Time Frame: 29 days. ]
  Assessment of pathogen eradication.
• Survival. [ Time Frame: 29 days ]
  Assessment of 28 days all cause mortality.

Information By: Combioxin SA

Dates:
Date Received: October 19, 2015
Date Started: March 2016
Date Completion: December 2017
Last Updated: December 12, 2016
Last Verified: December 2016