EUCTR2010-022168-11-SK进行中（未招募）不适用
A Phase 3 Randomized, Double-Blind, Multicenter Study Comparingthe Efficacy and Safety of 6-Day Oral TR-701 Free Acid and 10-DayOral Linezolid for the Treatment of Acute Bacterial Skin and SkinStructure Infections
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 658
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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:
- •? Induration
- •? Localized warmth
- •? Pain or tenderness on palpation
- •? At least 1 of the following systemic signs of infection:
- •? Lymph node tenderness and increase in volume or palpable proximal to the
- •primary ABSSSI
- •? Fever, defined as body temperature = 38°C (100.4°F) oral, = 38.5°C (101.2°F)
- •tympanic, or = 39°C (102.2°F) rectal (observed by a health care provider)
- •? White blood cell (WBC) count = 10,000 cells/mm3 or < 4000 cells/mm3
- •? > 10% immature neutrophils
- •B. Major cutaneous abscess defined as an infection characterized by a collection of pus within the dermis or deeper that is accompanied by all of the following within 24 hours:
- •? Erythema extending at least 5 cm from the peripheral margin of the abscess
- •? At least 1 of the following signs of infection:
- •? Fluctuance
- •? Incision and drainage required
- •? Purulent or seropurulent drainage
- •? Localized warmth
- •? Pain or tenderness on palpation
- •? At least 1 of the following systemic signs of infection:
- •? Lymph node tenderness and increase in volume or palpable proximal to the
- •primary ABSSSI
- •? Fever, defined as body temperature = 38°C (100.4°F) oral, = 38.5°C (101.2°F)
- •tympanic, or = 39°C (102.2°F) rectal (observed by a health care provider)
- •? WBC count = 10,000 cells/mm3 or < 4000 cells/mm3
- •? > 10% immature neutrophils
- •C. Wound Infection defined as an infection of any apparent break in the skin characterized by the following:
- •? Superficial incisional SSI meeting all of the following criteria:
- •? Follows clean surgery (elective, not emergency, nontraumatic, primarily closed,
- •no acute inflammation; no break in technique; respiratory, gastrointestinal,
- •biliary, and genitourinary tracts not entered)
- •? Involves only the skin or subcutaneous tissue around the incision, does not
- •involve fascia
- •? Occurs within 30 days after procedure
- •? Original surgical incision = 3 cm
- •? Purulent drainage from a wound with surrounding erythema extending at least 5
- •cm from the peripheral margin of the wound
- •? At least 1 of the following systemic signs of infection:
- •- Lymph node tenderness and increase in volume or palpable proximal to the
- •primary ABSSSI
- •- Fever, defined as body temperature = 38°C (100.4°F) oral, = 38.5°C
- •(101.2°F) tympanic, or = 39°C (102.2°F) rectal (observed by a health care
- •- WBC count = 10,000 cells/mm3 or < 4000 cells/mm3
- •- > 10% immature neutrophils
- 另有 9 项未显示
排除标准
- •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 at time of screening
- •5. ABSSSI due to or associated with any of the following:
- •? 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
- •? Diabetic foot infection, gangrene, or perianal abscess
- •? Concomitant infection at another site not including a secondary ABSSSI lesion (eg,
- •septic arthritis, endocarditis, osteomyelitis)
- •? Infected burns
- •? Decubitus or chronic skin ulcer, or ischemic ulcer due to peripheral vascular disease
- •(arterial or venous)
- •? Any evolving necrotizing process (ie, necrotizing fasciitis)
- •? Infected human or animal bites
- •? Infections at vascular catheter sites or involving thrombophlebitis
- •? Incisional SSI with any of the following characteristics:
- •? Follows clean-contaminated surgery (urgent or emergency case that is otherwise
- •clean, elective opening of respiratory, gastrointestinal, biliary, or genitourinary
- •tract with minimal spillage [eg, appendectomy] not encountering infected urine or
- •bile; minor technique break)
- •? Follows contaminated surgery (nonpurulent inflammation; gross spillage from
- •gastrointestinal tract; entry into biliary or genitourinary tract in the presence of
- •infected bile or urine; major break in technique)
- •? Follows dirty surgery (purulent inflammation [eg, abscess]; preoperative
- •perforation of respiratory, gastrointestinal, biliary, or genitourinary tract)
- •? Extends into the fascial or muscle layers, organs, or spaces
- •6. Use of antibiotics as follows:
- •? Systemic antibiotic with gram-positive cocci activity for the treatment of any
- •infection within 96 hours before Dose 1 of study drug
- •? Patients who failed prior therapy for the primary infection site are also excluded
- •from enrollment
- •? Topical antibiotic on the primary lesion except for antibiotic/antiseptic-coated
- •dressing applied to the clean postsurgical wound
- •7. Administration of linezolid within 30 days before Dose 1
- •8. Recent history of opportunistic infections where the underlying cause of these infections is still active (eg, leukemia, transplant, acquired immunodeficiency syndrome [AIDS])
- •9. Receiving chronic systemic immunosuppressive therapy such as prednisone doses = 20 mg per day for = 3 of the last 12 months OR therapies that in the Investigator’s judgment could predispose to opportunistic infections
- •10. Receiving treatment for active tuberculosis
- •11. Last known CD4 count < 200 cells/mm3 in patients with AIDS
- •12. Current or anticipated neutropenia with ANC < 1000 cells/mm3
- •13. Severe renal disease defined as creatinine clearance (CrCl) < 30 mL/min estimated by the Cockcroft-Gault formula OR requirement for peritoneal dialysis, plasmapheresis, hemodialysis, venovenous dialysis, or other forms of renal filtration
- •14. ALT or AST = 5 upper limit of normal OR moderate to severe hepatic disease with Child-Pugh score =7 defined by the following:
- •? Presence of ascites upon examin
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