Clinical trial NCT01519492 (phase 2, status: completed)
Conditions: skin and subcutaneous tissue bacterial infections, wound infection, cutaneous abscess, burn infection, cellulitis
ICD codes: O86.00, O86.01, O86.02, O86.09, O86.03, L03.213, L03.90, L03.211, L03.221, L03.314, L03.315, L03.316
Drugs: afn-12520000
SMILES: CN(CC1=C(C)C2=CC=CC=C2O1)C(=O)\C=C\C1=CC2=C(NC(=O)CC2)N=C1
Eligibility criteria:

        Inclusion Criteria:

          -  Provide written informed consent and to understand the demands of the protocol;

          -  Ages of 18 and 70 years, inclusive;

          -  Have clinically documented ABSSSI suspected or documented to be caused by
             staphylococci accompanied by redness, edema, and/or induration of a minimum surface
             area of 75 cm2 and can be categorized as one or more of the following: Wound
             infection; Cutaneous abscess Burn infection (≤20% of total body surface area) or
             Cellulitis

          -  Have a primary infected lesion with at least three of the following: Significant pain
             or tenderness to palpation; Purulent or seropurulent drainage or discharge; Erythema;
             Fluctuance; Induration; Edema; Heat or localized warmth;

          -  Have at least two of the following signs and symptoms of systemic inflammation or
             complicating factors: Documented or reported fever >38.0°C; WBC count of >10,000
             cells/mm3; Greater than 15% immature neutrophils irrespective of total WBC; Elevated
             CRP or ESR; or Local/regional lymphadenopathy;

          -  Have a Gram stain with Gram-positive cocci in clusters or PCR result indicating an
             infection with Staphylococci.

          -  Have clearly failed as defined in the protocol previous treatment after a minimum of
             48 hours

          -  Women of childbearing potential must have a negative pregnancy test at screening
             before enrollment

          -  Male and Female patients must utilize a highly effective method of contraception

          -  In the judgment of the Investigator have an expectation of survival and prompt
             improvement with effective oral antibiotic therapy and appropriate supportive care for
             the anticipated duration of the study

          -  Willing and able to comply with all the study activities and procedures in the
             hospital or clinic.

        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