Pneumonia Due to Staphylococcus Aureus Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Assess the Safety, Pharmacokinetics, Efficacy and Pharmacodynamics of KBSA301 in Severe Pneumonia (S. Aureus)
The objectives of this study are to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and clinical outcome of patients who have severe pneumonia caused by Staphylococcus aureus (S. aureus) after a single intravenous administration of KBSA301 in addition of standard of care antibiotic treatment.
S. aureus is a leading cause of bloodstream, skin, soft tissue, and lower respiratory tract
infections worldwide. The frequencies of both nosocomial and community-acquired S. aureus
infections have increased steadily over the years and the treatment of these infections has
become more challenging due to the emergence of multi-drug resistant strains (e.g.
methicillin-resistant Staphylococcus aureus).
S. aureus has several virulence factors that contribute to the pathogenesis of the infection.
Amongst them, alpha-toxin that is involved in the pathogenesis of pneumonia, as it leads to
apoptosis and cell lysis, in particular lymphocytes, macrophages, alveolar epithelial cells,
pulmonary endothelium, and thrombocytes.
In spite of preventive measures for S. aureus infections and current medical treatment
(mostly antibiotic therapy, alone or in combination), there is a clear unmet medical need in
the clinic for additional treatment options. Passive immunotherapy with monoclonal antibodies
may improve treatment options for severe and life-threatening infections like those caused by
S. aureus.
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