EUCTR2004-002914-12-LT进行中（未招募）不适用
A phase 3, Randomized, Double-Blind, Multinational Trial of Intravenous Televancin Versus Vancomycin for Treatment of Complicated Gram-positive Skin and Skin Structure Infections with a focus on Patients with infections Due to Methicillin-resistant Staphylococcus aureus
Theravance Inc.0 个研究点目标入组 1,200 人开始时间: 2005年2月10日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,200
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) Males and Females greater than or equal to 18 years of age
- •2) Patients must have a diagnosis of one of the following complicated skin and skin structure infections with MRSA either suspected or confirmed as the major cause of the infection:
- •-major abscess requiring surgical incision and drainage
- •-infected burn
- •-deep/extensive cellulitis
- •-infected ulcer
- •-wound infections
- •3) Patients must be expected to require at least 7 days of intravenous antibiotic treatment.
- •4) The following symptoms/signs must be present at the time of enrollment:
- •Purulent drainage or collection, OR at least 3 of the following:
- •-fluctuance
- •-heat and/or localised warmth
- •-pain and/or tenderness to palpation
- •-swelling and/or induration
- •-fever (as defined as >38oC/100.4oF orally, rectally or tympanically)
- •-WBC count > 10,000/mm3
- •->15% immature neutrophils (bands) irrespective of WBC count
- •5) Accessible site for culture
- •6) Informed consent can be obtained for participation in this study as defined by the local Institutional Review Board or Ethics Committee
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) a. Received more than 24 hrs of potentially effective systemic (IV/IM or PO) antibiotic therapy prior to randomisation, unless the pathogen was resistant to prior treatment or the patient was a treatment failure (no clinical improvement after 3 days),
- •b. Requires a non-study systemic (IV/IM or PO) antibacterial regimen to which the target pathogen is susceptible.
- •2) Requirement for concomitant administration of agents containing a cyclodextrin solubilizer such as intravenous Sporanox® (itraconazole) or Vfend® (voriconazole).
- •3) Patients with baseline QTc >500 msec, congenital long QT syndrome, uncompensated heart failure, uncorrected abnormal K+ or Mg++ blood levels or severe left ventricular hypertrophy.
- •4) Uncomplicated skin and superficial skin structure infection (e.g. simple abscess, impetiginous lesion, furuncle or superficial cellulitis).
- •5) Self-limited infection (e.g. isolated folliculitis or other infection that has a high surgical incision cure rate, or furunculosis or carbunculosis that is not associated with a cellulitis at least 2cm in radius).
- •6) Superinfected eczema, hidradenitis suppurativa or other chronic medical conditions (e.g. atopic dermatitis) where inflammation may be prominent for an extended period even after successful bacterial eradication.
- •7) Concurrent infections of unremovable prosthetic materials (e.g. permanent cardiac pacemaker battery packs, or joint replacement prosthesis).
- •8) Concurrent presence of osteomyelitis, endocarditis or other deep site tissue infection other than skin and skin structure infection.
- •9) Infections due to Gram-positive organism known to be resistant to vancomycin (e.g. vancomycin-resistant enterococcus) or Gram-negative organisms known to be resistant to aztreonam.
- •10) Burns involving >20% of body surface area or third degree/full-thickness in nature, diabetic foot ulcers, ischemic ulcers/wounds, necrotising fasciitis, gas gangrene, or mediastinitis.
- •11) Severely neutropenic (absolute neutrophil count < 500 cells/mm3) or anticipated to develop severe neutropenia during the study treatment period due to prior or planned chemotherapy or have HIV with known CD4 count < 100 cells/mm3 during the last 6 months.
- •12) Known hypersensitivity to or intolerance of study medications or their formulation excipients.
- •13) a. Female patients of childbearing potential if they are pregnant, nursing or unable to use a highly effective method of birth control during the study and for at least one month following the last dose of study medication. A negative serum pregnancy test must be documented prior to treatment. A highly effective method of birth control is defined as one that results in a low failure rate (i.e. < 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some IUD's, sexual abstinence, or a vasectomised partner.
- •b. Male patients must agree to use medically acceptable birth control for at least three months following last dose of study medication. A vasectomy or a condom used with a spermicide is a medically acceptable birth control method for males.
- •14) Prior enrollment in a clinical trial of telavancin.
- •15) Treatment with another investigational medication/device within 30 days of study entry.
- •16) Patients in shock or who are unlikely to survive through the treatment and evaluation period.
- •17) Patients unable to comply with the study procedures.
- •18) Any other condition which, in the opinion of an investigat
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