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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
48
Site 83
Jacksonville, Florida, United States
Site 81
Oklahoma City, Oklahoma, United States
Site 80
Houston, Texas, United States
Efficacy Endpoint: All-Cause Mortality by Day 28
A summary of the number (%) of patients who died on or before Day 28 (mITT population) is provided, by treatment group and overall.
Time frame: At Day 28 post infusion (Day 0)
Efficacy: All-Cause Mortality (End Of Study [EOS])
A summary of the number (%) of patients who died on or before timepoints Day EOS (mITT population) is provided, by treatment group (overall) and placebo.
Time frame: Patients who died during the specified timepoints (by EOS), up to day 107
Efficacy: All-Cause Mortality (Day 14)
A summary of the number (%) of patients who died on or before timepoints Day 14 visit (mITT population) is provided, by treatment group (overall) and placebo.
Time frame: Patients who died during the specified timepoints (Day 14)
Efficacy: All-Cause Mortality (Day 7)
A summary of the number (%) of patients who died on or before timepoints Day 7 visit (mITT population) is provided, by treatment group (overall) and placebo.
Time frame: Patients who died during the specified timepoints (Day 7)
Efficacy: All-Cause Mortality (Day 21)
A summary of the number (%) of patients who died on or before timepoints Day 21 visit (mITT population) is provided, by treatment group (overall) and placebo.
Time frame: Patients who died during the specified timepoints (Day 21)
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Brussels, Belgium
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Liège, Belgium
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Angers, France
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Angoulême, France
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Argenteuil, France
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Colombes, France
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Dijon, France
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