EUCTR2008-005166-31-HU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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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
- 性别
- All
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
- •- 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;
- •- 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
- •- 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
- •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.
研究者
相似试验
进行中（未招募）
不适用
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 OldComplicated Intra-Abdominal InfectionMedDRA version: 14.1Level: LLTClassification code 10056570Term: Intra-abdominal infectionSystem Organ Class: 10021881 - Infections and infestationsEUCTR2008-005166-31-Outside-EU/EEAWyeth Pharmaceuticals Inc., acting through its division Wyeth Research, a Pfizer Company300
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 OldMedDRA version: 9.1Level: LLTClassification code 10056570Term: Intra-abdominal infectionComplicated Intra-Abdominal InfectionEUCTR2008-005166-31-SIWyeth Pharmaceuticals Inc., acting through its division Wyeth Research, a Pfizer Company300
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 OldComplicated Intra-Abdominal InfectionEUCTR2008-005166-31-BEWyeth Pharmaceuticals Inc., acting through its division Wyeth Research, a Pfizer Company300
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 OldMedDRA version: 9.1 Level: LLT Classification code 10056570 Term: Intra-abdominal infectionComplicated Intra-Abdominal InfectionEUCTR2008-005166-31-GBWyeth Pharmaceuticals Inc., Acting through its division Wyeth Research, a Pfizer Company300
已完成
不适用
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-K65-A499 Bacterial infection, unspecifiedBacterial infection, unspecifiedA499K65PER-103-09WYETH RESEARCH,