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

CEREXA INC.,0 个研究点目标入组 0 人开始时间: 2012年4月24日最近更新: 2023年9月4日

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•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 7 DAYS BEFORE RANDOMIZATION. A MAJOR ABSCESS” EITHER EXTENDS TO DEEPER SOFT TISSUE OR REQUIRES SIGNIFICANT SURGICAL INTERVENTION. INCISION AND DRAINAGE SHOULD BE CONDUCTED WITHIN 24 HOURS AFTER FIRST DOSE OF IV STUDY DRUG. A MINIMUM AREA OF SURROUNDING ERYTHEMA (CELLULITIS ) AROUND THE ABSCESS IS REQUIRED FOR A SUBJECT TO BE ENROLLED IN THE STUDY; REFER TO APPENDIX I FOR CALCULATION AND MINIMUM SIZE REQUERIMENT.

•SUBJECTS MUST NOT MEET ANY OF THE FOLLOWING EXCLUSION CRITERIA:
•1. DOCUMENTED HISTORY OF ANY HYPERSENSITIVITY OR ALLERGICAL REACTION TO VANCOMYCIN, AZTREONAM, OR ANY-LACTAM ANTIMICROBIAL.
•2. UNCOMPLICATED SKIN AND SOFT TISSUE INFECTIONS SUCH AS SIMPLE ABSCESS, IMPETIGINOUS LESIONS, SUPERFICIAL OR SMALL SIZE CELLULITIS, FURUNCULOSIS, CARBUNCULOSIS, OR FOLLICULITIS.
•3. SKIN AND SKIN STRUCTURE INFECTIONS WITH A HIGH CURE RATE AFTER SURGICAL INCISION ALONE OR AFTER AGGRESSIVE LOCAL SKIN CARE.
•4. SKIN AND SOFT TISSUE INFECTIONS WITH ANY OF THE FOLLOWING CHARACTERISTICS:
•. KNOWN OR SUSPECTED ANAEROBIC PATHOGENS, PSEUDOMONAS, PAOTEUS, OR ESBL-PRODUCING ORGANISMS.
•. KNOWN OR SUSPECTED FUNGAL, PARISITIC, OR VIRAL PATHOGENS AS THE CAUSE FOR THE ABSSSI.
•. DECUBITIS ULCER OR DIABETIC FOOT INFECTION.
•. COMPLICATED BY OSTEOMYELITIS, SEPTIC ARTHRITIS, OR ENDOCARDITIS.
•. BURN WOUND.
•. UNDERLYING INFLAMMATORY SKIN DISEASE THAT MAY OBSCURE DETERMINATION OF RESPONSE, SUCH AS ATOPIC DERMATITIS.
•. HUMAN OR ANIMAL BITE.
•. RAPIDLY NECROZITING PROCESS SUCH AS NECROTIZING FASCIITIS
•. GANGRENE.
•. PRESENCE OF PROSTHETIC MATERIALS.
•. NEED FOR AMPUTATION.
•5. FAILURE OF VANCOMYCIN, AZTREONAM, OR A CEPHALOSPORIN AS THERAPY FOR THE CURRENT ABSSSI

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