Prevention of S. Aureus Pneumonia Study in Mechanically Ventilated Subjects Who Are Heavily Colonized With S. Aureus.



Status:Completed
Conditions:Pneumonia, Pneumonia
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:11/3/2018
Start Date:November 2016
End Date:September 19, 2018

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A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Safety and Efficacy of a Single Dose of ASN100 for the Prevention of Staphylococcus Aureus Pneumonia in Heavily Colonized, Mechanically Ventilated Subjects

The purpose of this study is the prevention of Staphylococcus aureus pneumonia in
mechanically ventilated subjects heavily colonized with S. aureus. Staphylococcus aureus is a
human pathogenic bacterium that causes severe infections, including pneumonia and sepsis.
Hospital-acquired bacterial pneumonia (HABP) caused by S. aureus, including
ventilator-associated bacterial pneumonia (VABP) in mechanically ventilated subjects, is a
significant public health threat despite efforts to optimize antibiotic treatment. ASN100 is
an investigational monoclonal antibody product that targets the toxins produced by S. aureus
to protect subjects from developing S. aureus pneumonia.

This is a double-blind, randomized, single-dose, placebo-controlled study of ASN100 for the
prevention of S. aureus pneumonia in mechanically ventilated subjects who are heavily
colonized with S. aureus. This will be a global study conducted at approximately 65 sites to
assess the safety, tolerability, and efficacy of ASN100.

Eligible subjects who meet all of the inclusion criteria and none of the exclusion criteria
will be screened by semi-quantitative culture of an endotracheal aspirate (ETA) to identify
those who are heavily colonized with S. aureus (3+ to 4+). Upon determination of eligibility,
subjects will be randomized in a 1:1 ratio to 1 of 2 treatment groups, ASN100 or placebo.

Inclusion Criteria:

- Subject is currently hospitalized and is mechanically ventilated endotracheally (i.e.,
orotracheal or nasotracheal) and, in the Investigator's opinion, will require ongoing
ventilator support for at least 48 hours;

Exclusion Criteria:

- Subject has a chest X-ray or thoracic computed tomography (CT) scan that is definitive
for a diagnosis of pneumonia

- Subject has a known and documented ETA culture showing heavy colonization with a
-Gram-negative organism at enrollment or at any time during the Screening period;

- Significant Neutropenia

- Severe non-pulmonary source of infection.

- Subjects with a known history or current (suspected) diagnosis of cytokine release
syndrome associated with the administration of peptides, proteins, and/or antibodies.
We found this trial at
17
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Buffalo, NY
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Aurora, CO
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Burlington, MA
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Charlotte, North Carolina 28207
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Georgetown, KY
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Hazard, KY
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Memphis, TN
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Wien,
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