EUCTR2014-004023-40-ES进行中（未招募）1 期
PHASE 3 STUDY OF IV TO ORAL 6-DAY TEDIZOLID PHOSPHATE COMPARED WITH 10-DAY COMPARATOR IN SUBJECTS 12 TO <18 YEARS WITH cSSTI
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
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
入选标准
- •?Males or females 12 years to <18 years
- •?Adequate venous access for IV administration of study drug for at least 24 hours
- •?Local symptoms must have started within 7 days before Study Day -1
- •?cSSTI meeting at least 1 of the clinical syndrome definitions.
- •?Suspected or documented Gram-positive infection from baseline Gram stain or culture.
- •?Parent/LAR able to give informed consent and willing and able to comply with all required study procedures. Assent is also required of children who in the Investigator's judgment are capable of understanding the nature of the study
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 162
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •?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 (eg, stitch abscesses)
- •?Known bacteremia, severe sepsis or septic shock
- •?Recent history of opportunistic infections where the underlying cause of these infections is still active (eg, leukemia, transplant, acquired immunodeficiency syndrome)
- •?Hypersensitivity to tedizolid phosphate or any component in the formulation
- •?Hypersensitivity to all of the comparator drugs; hypersensitivity to a comparator drug does not preclude participation if an alternative comparator can be used
- •?For subjects with wound infections: history of hypersensitivity to ceftazidime, aztreonam, or any component of the aztreonam formulation, if aztreonam adjunctive therapy is required; history of hypersensitivity to metronidazole or any component of the formulation, if metronidazole adjunctive therapy is required
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