NCT01431339已完成3 期
A Phase 3, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Dalbavancin to a Comparator Regimen (Vancomycin and Linezolid) for the Treatment of Acute Bacterial Skin and Skin Structure Infections
Durata Therapeutics Inc., an affiliate of Allergan plc5 个研究点 分布在 4 个国家目标入组 739 人开始时间: 2011年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 739
- 试验地点
- 5
- 主要终点
- Early Clinical Efficacy
研究概览
简要总结
The primary object is to compare the early clinical efficacy (after 48-72 hours of therapy) of dalbavancin to the comparator regimen (vancomycin with the option to switch to oral linezolid) for the treatment of patients with a suspected or proved gram-positive bacterial skin or skin structure infections.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients 18 - 85 years of age.
- •Signed and dated informed consent document.
- •Major abscess, surgical site infection, traumatic wound infection or cellulitis suspected or confirmed to be caused by Gram-positive bacteria.
- •At least two (2) local signs and symptoms of ABSSSI and at least one (1) systemic sign of infection.
- •Requires a minimum of 3 days of IV therapy.
- •Patient willing and able to comply with study procedures.
排除标准
- •Patients presenting with any of the following:
- •A contra-indication to any required study drug.
- •Pregnant or nursing females.
- •Sustained shock.
- •Participation in another study of an investigational drug or device within 30 days.
- •Receipt of a systemically or topically administered antibiotic within 14 days prior to randomization, except receipt of a single dose of a short-acting antibacterial drug 3 or more days prior to randomization.
- •Infection due to a dalbavancin or vancomycin-resistant organism.
- •Evidence of meningitis, necrotizing fasciitis, gas gangrene, gangrene, septic arthritis, osteomyelitis, and/or endovascular infection.
- •Exclusively gram-negative bacterial or a fungal ABSSSI.
- •Venous catheter infection.
- •Infection of a diabetic foot ulcer or a decubitus ulcer.
- •Device-related infections.
- •Gram-negative bacteremia.
- •Infected burns.
- •Infected limb with critical ischemia.
- •Superficial/simple skin and skin structure infections.
- •Concomitant condition requiring non-study antibacterial therapy.
- •ABSSSI requiring therapy for longer than 14 days.
- •Adjunctive therapy with hyperbaric oxygen.
- •More than 2 surgical interventions for ABSSSI anticipated.
- •Chronic inflammatory condition precluding assessment of clinical response.
- •Absolute neutrophil count < 500 cells/mm
- •Human immunodeficiency virus (HIV) infection with a CD4 cell count < 200 cells/mm
- •Recent bone marrow transplant, > 20 mg prednisolone per day (or equivalent) or receiving immunosuppressant drugs after organ transplantation.
- •Regular, chronic antipyretic use in patients unable to modify during the first three days of study drug therapy.
- •Life expectancy less than 3 months.
- •Conditions that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results.
- •Prior participation in the study.
研究组 & 干预措施
Vancomycin with possible switch to oral linezolid
Active Comparator
干预措施: Vancomycin/Linezolid (Drug)
Dalbavancin
Experimental
干预措施: IV Dalbavancin (Drug)
结局指标
主要结局
Early Clinical Efficacy
时间窗: After 48-72 hours of therapy
Clinical response at 48-72 hours post study drug initiation, based on measurements of acute bacterial skin and skin structure infections (ABSSSI) lesion size and temperature
次要结局
- Clinical Status(Follow-Up Visit (day 28))
- >= 20% Reduction in Lesion Area(48-72 hours after the initiation of study therapy)
研究者
研究点 (5)
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