A Study of Safety, Tolerability, and Efficacy of AFN-12520000 in the Treatment of Acute Bacterial Skin and Skin Structure Infections Due to Staphylococci

Exclusion Criteria

• •Have any one of the following conditions:
• •* Chronically infected "diabetic foot ulcers" or infections of chronic non-healing wounds of peripheral sites in a patient with advanced peripheral vascular disease;
• •* A wound infection involving foreign body or prosthetic material that will not be removed within 48 hours of initiation of treatment;
• •* Infected abdominal wounds unable to be surgically closed;
• •* Necrotizing fasciitis, rapidly necrotizing infections, or gangrenous processes;
• •* Infected burn involving \>20% of the total body surface area;
• •* Infected bite from human or animal origin.
• •* Erysipelas or a primary infection suspected or documented to be due to streptococci or infection with a Gram-negative pathogen without evidence of a concomitant staphylococcal infection
• •* Evidence of either a Gram-negative or Gram-positive pathogen not susceptible to treatment with protocol-specified antibiotics and AFN-12520000; or
• •* An existing abscess that cannot be drained within 48 hours of initiation of treatment;
• •Unable to tolerate an oral formulation of antibiotic, have an underlying gastrointestinal disease (would be poorly absorbed or tolerated), have a medical condition or post-operative condition leading to significant gastrointestinal malabsorption, and/or are unable to tolerate a normal diet;
• •Have a known or suspected non-skin source of infection such as endocarditis, osteomyelitis, retroperitoneal abscess, septic arthritis, meningitis, or pneumonia;
• •Exhibit signs of severe sepsis:
• •Plans to have surgery utilizing general anesthetic during the study period (except surgery to remove a prosthetic device complicating the infection site or surgery to drain the abscess/wound within 48 hours);
• •Pregnant or breastfeeding women;
• •History of epilepsy, known seizure disorder, or history of severe and frequent migraine headaches;
• •Taken an investigational medication during the month prior to enrollment;
• •Prior exposure to the AFN investigational product;
• •Known hypersensitivity to the protocol specified antibiotic necessary for the treatment of Staphylococcus or the protocol-specified concomitant antibiotic for the treatment of bacterial co-pathogens present in the wound;
• •Treatment with any systemic antibiotic (excluding topical antibiotics), which is potentially effective against prevalent community or hospital isolates of Staphylococcus causing ABSSSI within 72 hours prior to enrollment and treatment with study medication unless the patient has clearly failed treatment;
• •Not expected to survive for at least 60 days after enrollment;
• •Anticipated amputation during the study of the limb involving the primary site of infection;
• •History of human immunodeficiency virus infection with a current or previous CD4 count \<200/mm3;
• •Presence of immunodeficiency or an immunocompromised condition including hematologic malignancy, bone marrow transplant, or receiving immunosuppressive therapy such as cancer chemotherapy, medications for the rejection of transplantation, and long-term (≥2 weeks) use of systemic corticosteroids;
• •Neutropenia
• •End-stage renal disease or significant hepatic insufficiency
• •Need for protocol defined prohibited concomitant treatments
• •Unable or unwilling, in the judgment of the Investigator, to comply with the protocol
• •An employee of the Investigator or study center with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as a family member of the employee or the Investigator