EUCTR2008-005166-31-GB进行中（未招募）1 期
A Phase 3, Multicenter, Randomized, and Double-blind Study to Evaluate the Safety of Tigecycline versus a Ceftriaxone Regimen in the Treatment of Complicated Intra-abdominal Infections and Community-acquired Pneumonia 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 300 人开始时间: 2009年9月17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
- 300
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
- •1. Male or female subjects 8 to 17 years old. Children with bone maturation less than 8 years old should be enrolled with caution due to potential risk of tooth discoloration.
- •2. Have a diagnosis of a serious infection (cIAI) requiring hospitalization and administration of IV antibiotic therapy.
- •3. Anticipated length of antibiotic therapy greater than or equal to 5 days. 4. The following criteria must also be satisfied:
- •a) Be scheduled for or within 48 hours before screening have had a laparotomy, laparoscopy, or transrectal or percutaneous drainage of an intra-abdominal abscess. b) Have a cIAI which would include clinical entities such as (the following are examples): - complicated appendicitis [e.g., gangrenous, perforation (grossly visible) and abscess and/or periappendicular abscess]; - purulent peritonitis or peritonitis associated with fecal contamination; - intra-abdominal abscess, including those that develop in a post-operative subject; and - viscus perforation (with evidence of peritonitis or intra-abdominal abscess) with symptoms lasting at least 12 hours before operation.
- •c) Have at least 1 of the following signs of systemic infection: - fever (within the 24 hours before randomization) defined as a core temperature >38.5 degree C or <36 degree C (other methods are accepted); - white blood cell (WBC) count >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; and - 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).
- •d) Have at least 2 of the following signs and symptoms: - abdominal tenderness or pain; - abdominal mass on physical examination; - ileus or hypoactive bowel sounds; and - evidence or suspicion of an intra-abdominal abscess by radiography, scintigraphy, ultrasonography, computerized tomography (CT) scan, or magnetic resonance imaging (MRI).
- •5. 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.
- •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. Subject with any concomitant illness/condition 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 (e.g., life expectancy <30 days).
- •2. Received more than 24 hours of potentially effective systemic antibiotic therapy before first dose of test article (except if for prophylactic/perioperative use) to treat the current 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: Subject may not have failed therapy with any antibiotic where cross resistance would be expected with an antibiotic used in this study.
- •3. Infection due to a pathogenic organism known or suspected to be resistant to the study related antibiotics the subject may receive (e.g., before test article administration).
- •4. Subjects with any of the following conditions: - viscus perforation without evidence of peritonitis or intra-abdominal abscess; - pelvic inflammatory disease (any infection of the female genital-urinary track); - endocarditis; - infected device that will not be removed; - cystic fibrosis; - active tuberculosis; - congenital immunodeficiency; - meningitis; - severe sepsis; - refractory shock (e.g., in which hemodynamic parameters cannot be maintained despite adequate volume replacement); - confirmed malignancy in a subject receiving active course(s) of chemotherapeutic agents; - known or suspected infection with human immunodeficiency virus (HIV) (e.g., positive HIV antibody); - known or suspected concomitant infection requiring systemic treatment; - suspected inflammatory bowel disease.
- •5. Contraindication or hypersensitivity to any of the test articles that the subject may receive, including tetracycline (e.g., anaphylaxis).
- •6. 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.
- •7. Concurrent hemodialysis, hemofiltration, peritoneal dialysis, or plasmapheresis.
- •8. 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 the upper limit of normal (ULN); and - Bilirubin >3 x ULN, unless isolated hyperbilirubinemia is directly related to the acute process. 9. Participated in any investigational studies of drugs or devices within 4 weeks before administration of the first dose of test article.
- •10. Pregnant or nursing female.
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