NCT00488306已完成4 期
A Multicenter, Open Label Study to Evaluate the Efficacy and Safety of Tigecycline to Treat Complicated Intra-Abdominal Infections (cIAI) in Hospitalized Patients
Wyeth is now a wholly owned subsidiary of Pfizer1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2006年8月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The primary efficacy endpoint will be clinical response within the clinically evaluable population at the test-of-cure assessment.
研究概览
简要总结
In light of tigecycline's activity against these resistant bacteria, tigecycline may represent a viable new therapy for complicated intra-abdominal infections.
详细描述
To evaluate the efficacy and safety of tigecycline to treat complicated intra-abdominal infections in hospitalized patients. Both the clinical response profile and the microbiological response profile will be assessed. The primary endpoint will be clinical response within the microbiological evaluable population at the test-of-cure assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized male or female patients greater than or equal to 18 years of age.
- •Patients must be a candidate for or have had a laparotomy, or laparoscopy of an intra-abdominal abscess.
- •Patients with a complicated intra-abdominal infection such as:
- •an intra-abdominal abscess;
- •an intra-abdominal abscess (including liver and spleen) that develops in a post-operative patient after receiving > 48 hours and less than or equal to 5 days of a non-study antibiotic. An intra-abdominal culture must be obtained from the infected site.
- •appendicitis complicated by perforation (grossly visible) and abscess and/or periappendiceal abscess;
- •perforated diverticulitis complicated by abscess formation or fecal contamination;
- •complicated cholecystitis with evidence of perforation or empyema;
- •perforation of the large or small intestine with abscess, or fecal contamination;
- •purulent peritonitis or peritonitis associated with fecal contamination;
- •gastric or duodenal ulcer perforation with symptoms lasting at least 24 hours prior to operation;
- •traumatic bowel perforation with symptoms lasting at least 12 hours prior to operation.
排除标准
- •Patients with any concomitant condition that, in the opinion of the investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy or follow-up visits could be completed.
- •Active or treated leukemia or systemic malignancy that required treatment with chemotherapy, immunotherapy, radiation therapy or antineoplastic therapy within the past 3 months, or any metastatic malignancy to the abdomen with life expectancy less than 6 months.
- •Anticipated length of antibiotic therapy less than 5 days.
结局指标
主要结局
The primary efficacy endpoint will be clinical response within the clinically evaluable population at the test-of-cure assessment.
次要结局
- microbiological response (eradicated, persistence, superinfection, or indeterminate) at the patient level, microbiological response (eradicated, persistence, or indeterminate) at the pathogen level (overall and resistant pathogens) clinical
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Study Comparing the Safety and Efficacy of Tigecycline With Ampicillin-Sulbactam or Amoxicillin-Clavulanate to Treat Skin InfectionsSkin Diseases, BacterialNCT00368537Wyeth is now a wholly owned subsidiary of Pfizer550
已完成
4 期
Open Label Non-comparative Clinical Trial of Tigecycline in Patients With Catheter InfectionStaphylococcal InfectionsNCT00419991CPL Associates10
已完成
3 期
Study Evaluating Tigecycline in Selected Serious Infections Caused by Vancomycin-Resistant Enterococcus (VRE) or Methicillin-Resistant Staphylococcus Aureus (MRSA)Gram-Positive Bacterial InfectionsStaphylococcus InfectionsVancomycin ResistanceMethicillin ResistanceNCT00079976Wyeth is now a wholly owned subsidiary of Pfizer174
已完成
3 期
Study Evaluating Emergency-use Tigecycline in Subjects With Resistant Pathogens.Bacterial InfectionsNCT00205816Wyeth is now a wholly owned subsidiary of Pfizer26
已完成
4 期
Study Evaluating the Safety and Efficacy of Tigecycline in Hospitalized Patients With cSSSISkin Diseases, InfectiousNCT00488761Wyeth is now a wholly owned subsidiary of Pfizer50