NCT00366249已完成3 期

A Multicenter, Randomized, Double-Blind, Comparison Study of the Safety and Efficacy of a Once-Daily Dose of Tigecycline Versus Ertapenem for the Treatment of Foot Infections in Subjects With Diabetes

Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 1,061 人开始时间: 2007年1月最近更新: 2010年4月28日

研究概览

简要总结

The purpose of this study was to look at the safety and effectiveness of a once-daily dose of tigecycline compared to ertapenem for the treatment of diabetic foot infections. The co-primary efficacy endpoints were not met.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Triple (Participant, Care Provider, Investigator)

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

未提供

排除标准

未提供

研究组 & 干预措施

A

Active Comparator

干预措施: Tigecycline (Drug)

B

Active Comparator

干预措施: Ertapenem (Drug)

结局指标

主要结局

Number of Patients With Clinical Response of Cure Vs. Failure.

时间窗: Test of cure visit (TOC): Assessed at least 12 days post last dose

Cure: Recovery so no added antibiotic therapy. Failure: Added antibiotic therapy for no response or worsening after improvement, new purulence, \>120% doses, non-routine surgical treatment or death related to Diabetic Foot Infections (DFI) \> 48 hrs.

Number of Patients With Clinical Response of Cure Vs. Failure/Indeterminate.

时间窗: Test of cure visit (TOC): Assessed at least 12 days post last dose

Cure: Recovery so no added antibiotic therapy. Failure: Added antibiotic therapy for no response or worsening after improvement, new purulence, \>120% doses, non-routine surgical treatment or death related to DFI \> 48 hrs. Indeterminate: Lost to follow-up, death\<48 hours or noninfection related.

次要结局

Number of Patients With Clinical Response of Cure Vs. Failure Assessed at Least 25 - 27 Weeks Post Last Dose.(Test of cure visit (TOC): Assessed at least 25 - 27 weeks post last dose)
Number of Patients With Clinical Response of Cure Vs. Failure/Indeterminate Assessed at Least 25 - 27 Weeks Post Last Dose.(Test of cure visit (TOC): Assessed at least 25 - 27 weeks post last dose)
Number of Patients With Microbiologic Response of Eradication.(Test of cure visit (TOC): Assessed at least 12 days post last dose)

研究者

发起方

Wyeth is now a wholly owned subsidiary of Pfizer

申办方类型

Industry

相似试验

已完成

2 期

Safety, Tolerability, and Immunogenicity of Two Formulations of V114 in Healthy Adults 50 Years of Age or Older (V114-006)Pneumococcal Infections

NCT02547649Merck Sharp & Dohme LLC690

已完成

3 期

Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative ColitisUlcerative Colitis

NCT02065557AbbVie101

已完成

3 期

Safety and Efficacy of BI 1744 CL in Patients With Chronic Obstructive Pulmonary Disease IIPulmonary Disease, Chronic Obstructive

NCT00796653Boehringer Ingelheim937

已完成

3 期

Safety and Efficacy of BI 1744 CL in Patients With Chronic Obstructive Pulmonary Disease IPulmonary Disease, Chronic Obstructive

NCT00793624Boehringer Ingelheim906

已完成

1 期

Safety, Efficacy, and Pharmacokinetics (PK) Study of Trans Sodium Crocetinate (TSC) in Patients With Intermittent ClaudicationIntermittent Claudication

NCT00725881Diffusion Pharmaceuticals Inc48