A MULTICENTER, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SINGLE-DOSE IV ORITAVANCIN VERSUS IV VANCOMYCIN FOR THE TREATMENT OF PATIENTS WITH ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTION (SOLO I)

The Medicines Company,0 个研究点目标入组 0 人开始时间: 2011年7月12日最近更新: 2023年9月4日

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•1. MALES OR FEMALES ≥ 18 YEARS OLD
•2. DIAGNOSIS OF ABSSSI SUSPECTED OR CONFIRMED TO BE CAUSED BY A GRAM-POSITIVE PATHOGEN REQUIRING AT LEAST 7 DAYS OF IV THERAPY. A SPECIMEN FOR CULTURE MUST BE OBTAINED BY AN APPROVED PROTOCOL METHOD ≤ 24 HOURS BEFORE THE FIRST DOSE OF STUDY DRUG. FINAL CULTURE RESULTS ARE NOT REQUIRED PRIOR TO INICIATION OF STUDY DRUG.
•2. AN ABSSSI WHICH INCLUDES ONE OF THE FOLLOWING INFECTIONS:
•A. WOUND INFECTIONS: THAT ARE EITHER TRAUMATIC OR SURGICAL IN ORIGIN DEFINED AS AN INFECTION CHARACTERIZED BY PURULENT DRAINAGE FROM A WOUND WITH SURROUNDING ERYTHEMA, EDEMA, AND/OR INDURATION OF A MINIMUM SURFACE AREA OF 75 CM ² (eg, THE SHORTEST DISTANCE OR ERYTHEMA, EDEMA AND/OR INDURATION EXTENDING AT LEAST 5 CM FROM THE PERIPHERAL MARGIN OF THE WOUND), ACCOMPANIED BY SIGNS AND SYSTEMIC INFLAMMATION SYMPTOMS AS LISTED BELOW. ONSET OF THIS INFECTION MUST HAVE OCCURRED WITHIN 7 DAYS PRIOR RANDOMIZATION AND NO LATER THAN 30 DAYS FOLLOWING TRAUMA OR SURGICAL PROCEDURE.
•B. CELLULITIS / ERYSIPELAS: A DIFUSE SKIN INFECTION CHARACTERIZED BY SPREADING AREAS OF ERYTHEMA, EDEMA, AND/OR INDURATION OF A MINIMUM SURFACE AREA OF 75 CM² (eg: MINIMUM LENGTH OF 10 CM AND WIDTH OF 7.5 CM), ACCOMPANIED BY SIGNS AND SYSTEMIC INFLAMMATION SYMPTOMS AS LISTED BELOW.

•1. PRIOR SYSTEMIC OR TROPICAL ANTIBACTERIAL THERAPY WITH ACTIVITY AGAINST SUSPECTED OR PROVEN GRAM-POSITIVE PATHOGENS WITHIN THE PRECEDING 14 DAYS UNLESS:
•A. THE CAUSATIVE GRAM-POSITIVE PATHOGEN (S) ISOLATED FROM THE ABSSSI SITE IS RESISTANT IN VITRO TO THE ANTIBACTERIAL (S) THAT WAS ADMINISTERED WITH DOCUMENTED CLINICAL PROGRESSION, OR
•B. DOCUMENTED FAILURE TO PREVIOUS ABSSSI ANTIBIOTIC THERAPY IS AVALAIBLE. DOCUMENTATION OF TREATMENT FAILURE MUST BE RECORDED (eg, RECORD IN PATIENT´S MEDICAL CHART OF WOUND SIZE PRIOR TO INITIAL TREATMENT WITH DEMONSTRATION OF PROGRESSION ON THERAPY, DISCUSSION WITH PRIOR TREATING PHYSICIAN, CONSULTATION OF PATIENT´S MEDICAL RECORDS, AND/OR CONSULTATION OF AVAILABLE DOCUMENTATION OF TREATMENT (eg: PRESCRIPTION) BEFORE STUDY RANDOMIZATION
•C. PATIENT RECEIVED A SINGLE DOSE OF A SHORT ACTING ANTIBACTERIAL THERAPY (eg, SURGICAL PROPHYLAXIS) THREE OR MORE DAYS BEFORE RANDOMIZATION (ie, PATIENTS CANNOT HAVE NOT RECEIVED ANY ANTIBIOTIC TREATMENT WITHIN 72 HOURS OF RANDOMIZATION).
•2. INFECTIONS ASSOCIATED WITH, OR IN CLOSE PROXIMITY TO, A PROSTHETIC DEVICE.
•3. SEVERE SEPSIS OR REFRACTORY SHOCK
•4. KNOWN OR SUSPECTED BACTEREMIA AT THE TIME OF SCREENING
•5. ABSSSI DUE TO OR ASSOCIATED WITH ANY OF THE FOLLOWING:

发起方

The Medicines Company,