CTRI/2023/12/060921已完成3 期
A Phase III, Prospective, Randomized, Double Blind, Double Dummy, Active Controlled, Comparative, Parallel Group, Multicenter Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Tedizolid Tablets 200 mg Versus Linezolid Tablets 600 mg in Adult Patients for the Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI). - NI
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 243
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Male or female patients aged between 18 to 65 years (both inclusive).
- •2. Patients with acute bacterial skin and skin structure infections (ABSSSI) meeting at least one of the clinical syndromes listed below and requiring oral antibacterial therapy. Local symptoms must have started within 7 days before the screening visit.
- •Cellulitis/erysipelas
- •Wound infection
- •Major cutaneous abscess
- •3. Patients with suspected or documented Gram-positive infection from baseline Gram stain or culture.
- •4. Patient with ability to understand and provide written, signed and dated informed consent form, which must have been obtained prior to any assessment performed.
- •5. Patients willing to comply with the protocol requirements.
排除标准
- •1. Patients with uncomplicated skin and skin structure infections such as furuncles, minor abscesses (area of suppuration not surrounded by cellulitis/erysipelas), impetiginous lesions, superficial or limited cellulitis/erysipelas, and minor wound infections (e.g., stitch abscesses).
- •2. Patients with infections associated with, or in close proximity to, a prosthetic device.
- •3. Patients with severe sepsis or septic shock.
- •4. Patients with known bacteremia at time of screening.
- •5. Patients with acute bacterial skin and skin structure infection (ABSSSI) due to or associated with any of the following:
- •Suspected or documented Gram-negative pathogens in patients that require an antibiotic with specific Gram-negative coverage.
- •Diabetic foot infections, gangrene, or perianal abscess
- •Concomitant infection at another site not including a secondary ABSSSI lesion (e.g., 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 (i.e., necrotizing fasciitis)
- •Infected human or animal bites. However, arthropod (e.g., insects, spiders, ‘bugs’) bites are allowed only if subject actually witnessed the arthropod bite through the skin in the area of the ABSSSI; these are not considered animal bites in this study
- •Infections at vascular catheter sites or involving thrombophlebitis
- •Incision surgical site infection 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 [e.g., appendectomy] not encountering infected urine or bile; minor technique break)
- •Follows contaminated surgery (non-purulent inflammation; gross spillage from gastrointestinal tract; entry into biliary or genitourinary tract in the presence of infected bile or urine; major break in technique; chronic open wounds to be grafted or covered)
- •Follows dirty surgery (purulent inflammation [e.g., abscess]; preoperative perforation of respiratory, gastrointestinal, biliary, or genitourinary tract)
- •Extends into the fascia or muscle layers, organs, or spaces
- •6. Patients with use of antibiotics as follows:
- •Systemic antibiotic with activity against Gram-positive cocci for the treatment of any infection within 24 hours before the first dose of study drug
- •Patients who failed prior therapy for the primary infection site are also excluded from enrollment
- •Topical antibiotic on the primary lesion within 24 hours before the first dose of study drug except for antibiotic/antiseptic-coated dressing applied to the clean post-surgical wound
- •7. Patients with administration of Linezolid within 30 days before the first infusion of the study drug.
- •8. Patients with recent history of opportunistic infections where the underlying cause of these infections is still active (e.g., leukemia, transplant, acquired immunodeficiency syndrome [AIDS]).
- •9. Patients 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 judgement could predispose to opportunistic infections.
- •10. Patients with chronic (daily for the previous 30 days) use of an
研究者
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