Individual Patient Expanded Access for AB-SA01, an Investigational Anti-Staphylococcus Aureus Bacteriophage Therapeutic

Armata Pharmaceuticals

Status

Treatments: Biological: AB-SA01

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT03395769

AB-SA01-EAP01

Details and patient eligibility

About

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 [e-mail] 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.

Sex

Volunteers: No Healthy Volunteers

Inclusion criteria

Exclusion criteria