Conditions: Pneumonia Due to Staphylococcus Aureus
Keywords: Pneumonia Monoclonal antibody Staphylococcus aureus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 48
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: 1 mg/kg KBSA301 arm 2: 3 mg/kg KBSA301 arm 3: 10 mg/kg KBSA301 arm 4: 20 mg/kg KBSA301 arm 5: KBSA301-placebo

Interventions: intervention 1: KBSA301 intervention 2: Placebo
Intervention descriptions: intervention 1: KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4. intervention 2: Placebo administered as a single intravenous infusion

Protocol document: