A PHASE 3 RANDOMIZED, DOUBLE-BLIND, MULTICENTER STUDY COMPARING THE EFFICACY AND SAFETY OF 6-DAY ORAL TR-701 FREE ACID AND 10-DAY ORAL LINEZOLID FOR THE TREATMENT OF ACUTE BACTERIAL SKIN INFECTIONS AND SKIN STRUCTURE

TRIUS THERAPEUTICS, INC,0 个研究点目标入组 11 人开始时间: 2011年2月25日最近更新: 2023年9月4日

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•1.MALES OR FEMALES ≥ 18 YEARS OLD
•2.ABSSSI MEETING AT LEAST 1 OF THE CLINICAL SYNDROME DEFINITIONS LISTED BELOW AND REQUIRING SYSTEMIC ORAL ANTIBIOTIC THERAPY. LOCAL SYMPTOMS MUST HAVE STARTED WITHIN 7 DAYS BEFORE THE SCREENING VISIT.
•A.CELLULITIS/ERYSIPELAS DEFINED AS A DIFFUSE SKIN INFECTION, CHARACTERIZED BY ALL OF THE FOLLOWING WITHIN 24 HOURS:
•RAPIDLY SPREADING AREAS OF ERYTHEMA OF A MINIMUM SURFACE AREA OF 75 CM²
•NO COLLECTION OF PUS APPARENT UPON VISUAL EXAMINATION (DIAGNOSIS STILL CONSISTENT WITH CELLULITIS/ERYSIPELAS IF PUS IS COLLECTED FROM THE LESION)
•AT LEAST 1 OF THE FOLLOWING SIGNS OF INFECTION:
•O INDURATION
•O LOCALIZED WARMTH
•O PAIN OR TENDERNESS ON PALPATION
•AT LEAST 1 OF THE FOLLOWING SYSTEMIC SIGNS OF INFECTION:
•O LYMPH NODE TENDERNESS AND INCREASE IN VOLUME OR PALPABLE PROXIMAL TO THE PRIMARY ABSSSI
•O FEVER, DEFINED AS BODY TEMPERATURE ≥ 38°C (101.2°F) ORAL, ≥ 38.5°C (101.2°F) TYMPANIC, OR ≥ 39°C (102.2°F) RECTAL (OBSERVED BY A HEALTH CARE PROVIDER)
•O WBC COUNT ≥ 10,000 CELLS/MM³ OR < 4000 CELLS/MM³
•O > 10% IMMATURE NEUTROPHILS

•1. UNCOMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS (SSSIS) SUCH AS FURUNCLES, MINOR ABSCESSES (AREA OF SUPPURATION NOT SURROUNDED BY CELLULITIS/ERYSIPELAS), IMPETIGINOUS LESIONS, SUPERFICIAL OR LIMITED CELLULITIS/ERYSIPELAS, AND MINOR WOUND INFECTIONS (EG, STITCH ABSCESSES)
•2. INFECTIONS ASSOCIATED WITH, OR IN CLOSE PROXIMITY TO, A PROSTHETIC DEVICE
•3. SEVERE SEPSIS OR SEPTIC SHOCK
•4. KNOWN BACTEREMIA
•5. ABSSSI DUE TO OR ASSOCIATED WITH ANY OF THE FOLLOWING:
•O SUSPECTED OR DOCUMENTED GRAM-NEGATIVE PATHOGENS IN PATIENTS WITH CELLULITIS/ERYSIPELAS OR MAJOR CUTANEOUS ABSCESS THAT REQUIRE AN ANTIBIOTIC WITH SPECIFIC GRAM-NEGATIVE COVERAGE. PATIENTS WITH WOUND INFECTIONS WHERE GRAM-NEGATIVE ADJUNCTIVE THERAPY IS WARRANTED MAY BE ENROLLED IF THEY MEET THE OTHER ELIGIBILITY CRITERIA
•O DIABETIC FOOT INFECTIONS, GANGRENE, OR PERIANAL ABSEESS
•O CONCOMITANT INFECTION AT ANOTHER SITE NOT INCLUDING A SECONDARY ABSSSI LESION (EG, SEPTIC ARTHRITIS, ENDOCARDITIS, OSTEOMYELITIS)
•O INFECTED BURNS
•O DECUBITUS OR CHRONIC SKIN ULCER, OR ISCHEMIC ULCER DUE TO PERIPHERAL VASCULAR DISEASE (ARTERIAL OR VENOUS)
•O ANY EVOLVING NECROTIZING PROCESS (IE, NECROTIZING FASCIITIS)
•O INFECTED HUMAN OR ANIMAL BITES
•O INFECTIONS AT VASCULAR CATHETER SITES OR INVOLVING THROMBOPHLEBITIS

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