Last updated on March 2018

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


Brief description of study

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 Study 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.

Clinical Study Identifier: NCT02583373

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Pierre-François LATERRE, Prof.

St Luc University Hospital
Brussels, Belgium

Herbert SPAPEN, MD

University Hospital Brussels
Brussels, Belgium

Thierry DUGERNIER, MD

Clinique St Pierre
Ottignies, Belgium

Jean-Christophe NAVELLOU, MD

CHU Jean Minjoz
Besancon, France

Gwenhael COLIN, MD

CHD Les Oudairies
La Roche-sur-Yon, France

Jean-Pierre Bedos, MD

H pital Mignot
Le Chesnay, France

Bruno FRANCOIS, MD

CHU Dupuytren
Limoges, France

Anne COURTE, MD

CH Yves Le Foll
Saint-Brieuc, France

Pierre-François DEQUIN, Prof

CHRU de Tours
Tours, France

Thierry BOULAIN, MD

Centre Hospitalier R gional d'ORLEANS
Orléans, France