PER-102-09已完成未知
A Phase 3, Multicenter, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Tigecycline Versus Clindamycin for the Treatment of Complicated Skin and Skin Structure Infections, Including Those due to MRSA, in Pediatric Subjects Ages 8 to 17 Years Old
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
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
- 年龄范围
- 8 至 17（—）
入选标准
- •Male or female subjects whose ages range between 8 and 17 years. Children with bone maturation under 8 years of age should enroll with caution due to the possible risk of discoloration of the teeth.
- •All subjects, both male and female who have a biological ability to conceive, must accept and commit to using a reliable method of contraception throughout the study and during the month following the last dose of the test product. (A subject has a biological ability to conceive even if he uses contraceptives or if his sexual partner is sterile or uses contraceptives).
- •Presence of a cSSSI that requires hospitalization and administration of IV antibiotic therapy with an expected duration of such therapy greater than or equal to 5 days.
- •Having a cSSSI that requires significant surgical intervention or that affects deeper soft tissue.
- •Have at least 3 of the following signs and symptoms: drainage and / or secretion; erythema; swelling and / or induration and / or fluctuation; localized heat; pain and / or tenderness.
排除标准
- •Subjects who suffer, any concomitant disease / pathology or who take any concomitant drug that, at the discretion of the investigator, substantially increases] the risk related to the participation of the subject in the study and / or the end of it, or that may prevent evaluation of the subject´s response (for example, life expectancy <3Ü days).
- •Be a pregnant or breastfeeding woman.
- •Have participated in a research study of drugs or devices within 4 weeks prior to the administration of the first dose of the test product.
- •Contraindication or hypersensitivity to any of the test products that the subject may receive, including tetracycline (for example, anaphylaxis).
- •Presence of necrotizing fasciitis, gas gangrene, or proven skeletal infection.
- •Have received potentially effective systemic antibiotics for more than 24 hours before the first dose of the test product to treat the current cSSSI infection, unless the subject has been declared a clinical failure (no clinical improvement was observed after 48 hours of treatment) Or it has been proven that the microorganism is resistant to tigecycline or clindamycin and vancomycin or agents of the same class.
- •Be suspected of infection or a proven infection caused by a pathogenic microorganism whose resistance to tigecycline or clindamycin and vancomycin is proven (for example, before administration of T.A.).
- •Subjects receiving immunosuppressive therapy that, at the discretion of the investigator, could reduce the subject´s ability to eradicate the infection, including the use of high doses of corticosteroids.
- •Hemodialysis, hemofiltration, peritoneal dialysis, or concurrent plasmapheresis.
研究者
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