EUCTR2008-001936-11-BE进行中（未招募）1 期
A Phase 3, Multicenter, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Tigecycline Versus Comparator (Clindamycin or Vancomycin) for the Treatment of Complicated Skin and Skin Structure Infections, Including Those due to MRSA, in Pediatric Subjects Ages 8 to 17 Years Old
Wyeth Pharmaceuticals Inc., acting through its division Wyeth Research, a Pfizer Company0 个研究点目标入组 400 人开始时间: 2009年3月12日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 400
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. Male or female subjects aged 8 to 17 years old. Children with bone maturation of less than 8 years old should be enrolled with caution due to potential risk of tooth discoloration. 2. All female and male subjects who are biologically capable of having children must agree and commit to the use of a reliable method of birth control for the duration of the study and for 1 month after the last dose of any test article (a subject is biologically capable of having children even if he or she is using contraceptives or if his or her sexual partner is sterile or using contraceptives). 3. Presence of a cSSSI requiring hospitalization and administration of IV antibiotic therapy with anticipated length of IV antibiotic therapy greater than or equal to 5 days. 4. Have a cSSSI requiring significant surgical intervention or involving deeper soft tissue. This would include clinical entities such as one of the following (note that the following are examples): - infected wound; - infected decubitus ulcers (eg, perianal area); - burns (<20% body surface area, non-full thickness); - major abscess (not treatable through surgery alone); - deep or extensive cellulitis (eg, =10 cm where anatomically applicable and/or serious facial localization); - infected human or animal bites. Note: subjects with peripheral IV catheter site infections with documented purulent drainage will not be eligible for inclusion. 5. Have at least 3 of the following signs and symptoms: - drainage and/or discharge; - erythema; - swelling and/or induration and/or fluctuance; - localized warmth; - pain and/or tenderness to palpation. 6. Presence of at least 1 of the following systemic signs of infection: - fever (within the 24 hours before randomization) defined as a core temperature >38.5 C or <36 C (other methods are accepted); - white blood cell (WBC) >13.5 x 109/L (13,500/mm3 for age 8 to 12), >11 x 109/L (11,000/mm3 for age 13 to 17), <4.5 x 109/L (4,500/mm3) or >10% immature neutrophils (bands); - positive blood culture; - any 2 of the following: systolic blood pressure <105 mm Hg (age 8 to 12) or <117 mm Hg (age 13 to 17), tachycardia >130 beats/min (age 8 to 12) or >110 beats/min (age 13 to 17), or respiratory rate >18 breaths/min (age 8 to 12) or >14 breaths/min (age 13 to 17).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •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
- •1. Subjects with any concomitant illness/condition or taking any concomitant medication that, in the investigator’s judgment, will substantially increase the risk associated with the subject’s participation in and/ or completion of the study, or could preclude the evaluation of the subject’s response (eg, life expectancy <30 days). 2. Pregnant or breastfeeding female. 3. Participated in any investigational studies on drugs or devices within 4 weeks before administration of the first dose of test article. 4. Contraindication or hypersensitivity to any of the test articles that the subject may receive, including tetracycline (eg, anaphylaxis). 5. Presence of necrotizing fascitiis, gas gangrene, or known skeletal infection. 6. Received more than 24 hours of potentially effective systemic antibiotic before the first dose of test article to treat the current cSSSI infection, unless subject has been declared a clinical failure (no clinical improvement after 48 hours of treatment) or the causative organism(s) has been shown to be resistant to prior antibiotics. Note: Subjects may not have failed therapy with any antibiotic where cross resistance would be expected with an antibiotic used in this study. 7. Known or suspected infection due to a pathogenic organism known to be resistant to tigecycline or both clindamycin and vancomycin (eg, before T.A. administration). 8. Subjects with any of the following conditions: - cystic fibrosis; - endocarditis; - infected device that will not be removed; - active tuberculosis; - congenital immunodeficiency; - meningitis; - severe sepsis; - refractory shock (eg, in which hemodynamic parameters cannot be maintained despite adequate volume replacement); - confirmed malignancy with subject receiving active course of chemotherapeutic agents; - known or suspected infection with human immunodeficiency virus (HIV) (eg, positive HIV antibody); - known or suspected concomitant infection requiring systemic treatment. 9. Subjects receiving immunosuppressive therapy that, in the opinion of the investigator, would decrease the subject’s ability to eradicate the infection, including use of high-dose corticosteroids. 10. Concurrent hemodialysis, hemofiltration, peritoneal dialysis, or plasmapheresis. 11. Presence of any of the following laboratory findings: - Neutropenia (absolute neutrophil count <1 X 109/L [<1000/mm3]); - Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >5 x upper limit of normal (ULN); - Bilirubin >3 x ULN.
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