Ceftobiprole in the Treatment of Patients With Acute Bacterial Skin and Skin Structure Infections

INCLUSION CRITERIA

• Male or female, aged ≥18 years.
• Diagnosis of ABSSSI, meeting at least one of the definitions in (a) to (c) below. Local symptoms must have started within the 7 days prior to the Screening visit:
• Cellulitis/erysipelas, defined as a diffuse skin infection characterized by all of the following within 24 hours:
• i. Rapidly spreading areas of erythema, edema, and/or induration with a minimum total lesion surface area of 75cm^2
• ii. No collection of pus apparent upon visual examination
• iii. At least two of the following local signs of infection:
• erythema
• induration
• localized warmth
• pain or tenderness on palpation
• swelling/edema
• Major cutaneous abscess, defined as infection characterized by a collection of pus within the dermis or deeper that is apparent upon visual examination before or after therapeutic intervention and is accompanied by all of the following within 24 hours:
• i. Erythema, edema and/or induration with a minimum total lesion surface area of 75 cm^2.
• ii. At least two of the following local signs of infection:
• fluctuance
• incision and drainage required
• purulent or seropurulent drainage
• localized warmth
• pain or tenderness on palpation
• Wound infection, defined as infection of any apparent break in the skin characterized by at least one of the following:
• i. Superficial incision/surgical site infection meeting all of the following criteria:
• involves only the skin or subcutaneous tissue around the incision (does not involve fascia).
• occurs within 30 days of procedure.
• purulent drainage (spontaneous or therapeutic) with surrounding erythema, edema and/ or induration with a minimum total lesion surface area of 75cm^2.
• ii. Post-traumatic wound (including penetrating trauma, e.g., needle, nail, knife, insect and spider bites) meeting the following criterion within 24 hours:
• Purulent drainage (spontaneous or therapeutic) with surrounding erythema, edema and/or induration with a minimum total lesion surface area of 75cm^2.
• At least one of the following regional or systemic signs of infection at the Screening visit:
• Lymph node tenderness and volume increase, or palpable lymph node proximal to the primary ABSSSI.
• Fever > 38 °C/100.4 °F measured orally, > 38.5 °C / 101.3 °F measured tympanically, > 37.5 °C / 99.5 °F measured by the axillary method, or > 39 °C / 102.2 °F measured rectally.
• White blood cell (WBC) count > 10.0 × 10^9/L or 10% immature neutrophils (band forms).
• Requirement for IV antibacterial treatment.
• Willing and able to adhere to study procedures (including prohibitions and restrictions) as specified in this protocol.
• Willing and able to remain hospitalized (in a hospital or equivalent medical confinement or clinical research unit) until completion of the early-clinical-response assessment for the primary endpoint.
• Informed consent signed by the patient, or their legally acceptable representative if appropriate, indicating that they understand the purpose of, and procedures required for, the study, and are willing to participate.

EXCLUSION CRITERIA

Patients meeting any one of the following:

• Use of any systemic antibacterial treatment within 14 days, or topical antibacterial administration on the primary lesion within 96 hours, before first infusion of study drug.

Exception: Receipt of a single dose of a short acting (half-life ≤ 12 hours) antibacterial therapy (e.g., for surgical prophylaxis) within > 3 days before randomization (i.e., patients cannot have received any antibacterial treatment within 72 hours of randomization).

• Contraindication to the administration of either of the study treatments, including known clinically-relevant hypersensitivity to related antibacterial treatments (e.g., beta-lactam and glycopeptide antibiotics), or to metronidazole if required as adjunctive therapy.
• Participation in any other clinical study within the 30 days prior to randomization, or any prior participation