A MULTICENTER, RANDOMIZED, OBSERVER-BLINDED, ACTIVE-CONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, EFFICACY, AND PHARMACOKINETICS OF CEFTAROLINE VERSUS COMPARATOR IN PEDIATRIC SUBJECTS WITH ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS

INTERVENTION: THE TOTAL DURATION OF IV PLUS PO THERAPY IS 5 TO 14 DAYS; A MINIMUM OF 3 DAYS OF IV THERAPY (72 HOURS OF CEFTAROLINE FOSAMIL OR COMPARATOR) IS REQUIRED. SUBJECTS MAY BE DISCHARGED FROM THE HOSPITAL ON OR AFTER STUDY DAY 4 AND CONTINUE IV STUDY DRUG ADMINISTRATION ON AN OUTPATIENT BASIS IF THEY MEET PRESPECIFIED CRITERIA (SECTION 9.4) THE INVESTIGATOR CONDUCTING CLINICAL ASSESSMENT WILL BE BLINDED TO STUDY DRUG THERAPY (REFERRED TO AS “BLINDED OBSERVER” HEREAFTER) AND AN UNBLINDED INVESTIGATOR WILL BE RESPONSIBLE FOR SUBJECT MANAGEMENT BASED ON MEDICAL INFORMATION. AN UNBLINDED PHARMACIST OR DESIGNEE WILL PREPARE THE IV STUDY DRUG INFUSIONS AND WILL DISPENSE THE OPEN‐LABEL PO STUDY DRUG. AT LEAST 270 SUBJECTS WILL BE ENROLLED AND RANDOMIZED (2:1) TO ENSURE A MINIMUM OF 180 SUBJECTS IN THE CEFTAROLINE FOSAMIL GROUP AND 90 SUBJECTS IN THE COMPARATOR GROUP. CONDITION: PRIMARY OUTCOME: Evaluate the safety and tolerability of ceftaroline versus comparator in pediatric subjects ages 2 months to < 18 years with ABSSSI through the monitoring of adverse events, vital signs evaluation and laboratory exams.; NAME OF THE RESULT: Evaluate the safety and tolerability of ceftaroline versus comparator in pediatric subjects ages 2 months to < 18 years with acute bacterial skin and skin structure infection.; USED MEASURING METHOD :Monitoring of adverse events and serious adverse events, as well as cephalosporine class efects; clincal exam; and required laboratory exams.; PERIOD OF TIME WHERE THE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Between 26 and 50 days. SECONDARY OUTCOME: Clinical response at Study Day 3 in the MITT Population ; NAME OF THE RESULT: Clinical response at Study Day 3 in the Modified intent‐to‐treat Population ; USED MEASURING METHOD :Evaluation in a blinded manner at Study Day 3 for each subject in MITT Popularion according to the following response definitions: ; ‐ Definition 1: ≥ 20% reduction from baseline in infection area (lengt x width) ; ‐ Definition 2: Cessation of spread relative to baseline as measured by area ; ‐ Definition 3: Cessation of spread relative to baseline as measured by length and width, separately, AND temperature <37.6°C, irrespective of temperature collection method. ; PERIOD OF TIME WHERE THE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE SECONDARY RESULT: Between 1 and 5 days. INCLUSION CRITERIA: SUBJECTS ARE REQUIRED TO MEET THE FOLLOWING INCLUSION CRITERIA: 1. INFORMED CONSENT IN WRITING FROM PARENT (S) OR LEGALLY ACCEPTABLE REPRESENTATIVE (S) AND, INFORMED ASSENT FROM SUBJECT (IF AGE APPROPIATE ACCORDING TO LOCAL REQUIREMENTS). 2. MALE OR FEMALE, 2 MONTHS TO < 18 YEARS OLD. 3. PRESENCE OF ABSSSI WARRANTING 3 DAYS OF INITIAL HOSPITALIZATION AND A MINIMUM OF 3 DAYS OF IV ANTIBACTERIAL THERAPY, BUT NO MORE THAN 14 DAYS OF TOTAL THERAPY (IV AND PO COMBINED). 4. PRESENCE OF ABSSSI WITH MEASURABLE MARGINS OF ERYTHEMA (CELLULITIS), THAT INCLUDES DEEPER AND/OR EXTENSIVE SOFT TISSUE INVOLVEMENT * (EG, DEEP AND EXTENSIVE CELLULITIS, ERYSIPELAS, OR MAJOR ABSCESS), OR REQUIRES SIGNIFICANT THERAPEUTIC SURGICAL INTERVENTION ** (EG, MAJOR ABSCESS OR AN INFECTED WOUND [POSTOPERATIVE SURGICAL OR TRAUMATIC]), DEFINED AS: . ABSCESS: PRESENCE OF A LOCULATED FLUID COLLECTION WITH ERYTHEMA (IE, CELLULITIS) EXTENDING FROM THE ABSCESS MARGIN AND ONSET WITHIN