NCT01252732已完成3 期
A Multicenter, Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of Single-Dose IV Oritavancin Versus IV Vancomycin for the Treatment of Patients With Acute Bacterial Skin and Skin Structure Infection (SOLO II)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,019
- 试验地点
- 1
- 主要终点
- Early Clinical Response
研究概览
简要总结
The purpose of this Phase 3 trial is to evaluate the efficacy, safety, and tolerability of oritavancin in ABSSSIs, including those caused by MRSA and to evaluate the potential economic benefit of oritavancin administered as a single 1200 mg IV dose.
详细描述
This is a Phase 3, multicenter, randomized, double-blind, parallel, comparative efficacy and safety study of single-dose IV oritavancin/IV placebo versus IV vancomycin for 7 to 10 days in adults with acute bacterial skin and skin structure infection (ABSSSI) suspected or proven to be caused by Gram-positive pathogens. Approximately 960 patients will be randomized at 100 centers globally.
In addition, this study will characterize the PK and PK/PD properties of a single 1200 mg IV dose of oritavancin and evaluate the potential health economic benefits offered by this dosing strategy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects may be included in the study if they meet all of the following inclusion criteria:
- •Males or females ≥18 years old
- •Diagnosis of ABSSSI suspected or confirmed to be caused by a Gram-positive pathogen requiring at least 5 days of IV therapy
- •An ABSSSI includes one of the following infections Wound infections, Cellulitis/erysipelas, Major cutaneous abscess
- •ABSSSI must present with at least 2 signs and symptoms
- •Able to give informed consent and willing to comply with all required study procedures
排除标准
- •Subjects will be excluded from the study if any of the following exclusion criteria apply prior to randomization:
- •Prior systemic or topical antibacterial therapy with activity against suspected or proven Gram-positive pathogens within the preceding 14 days
- •The causative Gram-positive pathogen(s) isolated from the ABSSSI site is resistant in vitro to the antibacterial(s) that was administered with documented clinical progression, or
- •Documented failure to previous ABSSSI antibiotic therapy is available. Documentation of treatment failure must be recorded
- •Patient received a single dose of a short acting antibacterial therapy three or more days before randomization
- •Infections associated with, or in close proximity to, a prosthetic device
- •Severe sepsis or refractory shock
- •Known or suspected bacteremia at time of screening
- •ABSSSI due to or associated with any of the following:
- •Infections suspected or documented to be caused by Gram-negative pathogens -- Wound infections (surgical or traumatic) and abscesses with only Gram-negative pathogens
- •Diabetic foot infections
- •Concomitant infection at another site not including a secondary ABSSSI lesion
- •Infected burns
- •A primary infection secondary to a pre-existing skin disease with associated inflammatory changes
- •Decubitus or chronic skin ulcer, or ischemic ulcer due to peripheral vascular disease
- •Any evolving necrotizing process gangrene or infection suspected or proven to be caused by Clostridium species
- •Infections known to be caused by a Gram-positive organism with a vancomycin MIC >2 μg/mL or clinically failing prior therapy with glycopeptides
- •Catheter site infections
- •Allergy or intolerance to aztreonam or metronidazole in a patient with suspected or proven polymicrobial wound infection involving Gram-negative and/or anaerobic bacteria
- •Currently receiving chronic systemic immunosuppressive therapy
- •AIDS with CD4 count < 200 cells/mm3
- •Neutropenia
- •Significant or life-threatening condition that would confound or interfere with the assessment of the ABSSSI
- •Women who are pregnant or nursing
- •History of immune-related hypersensitivity reaction to glycopeptides
- •Patients that require anticoagulant monitoring with an aPTT
- •Contraindication to vancomycin
- •Patients unwilling to forego blood and/or blood product donation
- •Treatment with investigational medicinal product within 30 days before enrollment and for the duration of the study
- •Investigational device present, or removed <30 days before enrollment, or presence of device-related infection
- •Patients unlikely to adhere to the protocol, comply with study drug administration, or complete the clinical study
- •Severe hepatic disease
- •Presence of hyperuricemia
- •Unwilling to refrain from chronic use of any medication with antipyretic properties
研究组 & 干预措施
Single-Dose IV Oritavancin Diphosphate
Experimental
干预措施: Single-Dose IV Oritavancin Diphosphate (Drug)
IV Vancomycin
Active Comparator
干预措施: IV Vancomycin (Drug)
结局指标
主要结局
Early Clinical Response
时间窗: 48-72 hours after the initation of study therapy
Clinical response at the ECE visit (48-72 hours following initiation of study drug administration). Early clinical response was defined as a composite outcome based on, cessation of spreading or reduction in the size of baseline lesion, absence of fever and no rescue antibiotic medication.
次要结局
- >= 20% Reduction in Lesion Area(48-72 hours after the initation of study therapy)
- Investigator Assessed Clinical Cure at Post Therapy Evaluation (Key Secondary Endpoint)(7 to 14 days after end of therapy)
研究者
研究点 (1)
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