None listed
Conditions
Brief summary
The purpose of the expanded access program is to allow physicians to provide treatment with investigational drug, AB-SA01, for patients with serious or immediately life-threatening Staphylococcus aureus infections, for which no alternative treatment(s) are currently available, and who meet the criteria for treatment under FDA's Expanded Access regulations and criteria set forth by AmpliPhi Biosciences Corporation. To be considered for expanded access, the request should be submitted to AmpliPhi by a qualified and licensed physician with expertise and facilities appropriate for the administration of the investigational medicine. Treating physicians should contact AmpliPhi by emailing expandedaccess@ampliphibio.com with Expanded Access Request in the subject line, and include in the email the treating physicians name, organization/hospital/institution, physical address, email address, telephone number, and a brief description of the indication/condition. Any approval of expanded access to investigational medicine must always comply with the applicable laws and regulations.
Interventions
AB-SA01 is an investigational bacteriophage therapeutic for treatment of Staphylococcus aureus infections
Sponsors
Eligibility
Inclusion criteria
\-
Exclusion criteria
\-