EUCTR2004-001200-12-IE进行中（未招募）1 期
inezolid In The Treatment Of Complicated Skin And Soft Tissue Infections Proven To Be Due To Methicillin-Resistant Staphylococcus Aureus
Pfizer Global Research and Development0 个研究点目标入组 1,200 人开始时间: 2004年11月11日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 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
入选标准
- •1.Male and female subjects with signs or symptoms consistent with infection, and if available, laboratory findings consistent with staphylococcal infection (e.g., Gram stain and culture results)
- •2.Subject or his/her legally acceptable representative must give informed consent by signing and dating an informed consent form prior to study entry
- •3.Subjects must be at least 18 years of age
- •4.Women of childbearing potential must use adequate contraception, defined as hormonal contraception, intrauterine device, or barrier methods (condom or vaginal diaphragm) with spermacide, throughout the study. The pre-study pregnancy test (urine or serum gonadotropin) must be negative. Women who have been surgically sterilized or are at least two years postmenopausal may be enrolled and do not have to use birth control. Women whose method of birth control is hormonal are required to use an additional barrier method during the study.
- •5.Subjects must be in a hospital environment or in process of thr referral to a hospital at the time of randomisation.
- •6. Subjects must be expected to survive with effective antibiotic therapy and appropriate supportive care throughout the period of treatment and follow-up
- •7.Subjects must be willing to complete all study related activities
- •8.Subjects who, after control of their acute infection, are likely to be eligible to be discharged to outpatient therapy
- •9.Subjects must have at least two of the specific signs and symptoms of an active skin or soft tissue infection caused by suspected MRSA that involves deep tissues such as subcutaneous tissue, fascia or skeletal muscle. Signs or symptoms may include:·purulent drainage·erythema ·swelling·induration·tenderness to palpation·pain·local warmth
- •10. Subjects should also have at least one of the following: ·elevated body temperature: (oral >38ºC/100.4ºF), (rectal >39ºC/102.2ºF), (axillary >37.5ºC/99.5ºF), (tympanically >38.5ºC/101.3ºF) that has occurred within the last twelve hours·hypotension:(systolic BP<90mmHg)·elevated total peripheral white blood cell count > 10,000/mm3 15% immature neutrophils (bands) regardless of total peripheral white count
- •11.Subjects must have venous access available for intravenous dosing
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Subjects who have received an investigational drug during the previous 30 days or five times the plasma half-life (if known), whichever is longer or who have previously participated in this trial or any other protocol using linezolid in the past 6 months
- •2.Subjects of childbearing potential, who are unable to take adequate contraceptive precautions, have a positive pregnancy test result within 24 hours prior to study entry, are otherwise known to be pregnant, or are currently breastfeeding an infant
- •3.Subjects with infected devices, where the device is not removed
- •4.Subjects with a hypersensitivity to vancomycin, oxazolidinones or any of the excipients in the IV or oral formulation of linezolid
- •5.Subjects with MRSA known to be resistant to either of the study drugs before study entry
- •6.Subjects who were treated with a previous antibiotic (systemic or topical) with MRSA activity (other then linezolid or vancomycin) for more than 24 hours, and treatment extended into 72 hours period prior to the first dose of study drug, unless documented to be a treatment failure (72 hours of treatment and not responding). Certain drugs with variable MRSA activity (e.g. fluoroquinolones) may not be excluded if local susceptibility patterns will predict resistance and resistance is subsequently documented (see section 5.3)
- •7.Subjects whowere treated with linezolid or vancomycin for more than 24 hours may not be enrolled, and extended into the 72 hour period prior to the first dose of study drug.
- •8.Subjects with known or suspecting necrotizing fasciitis, gas gangrene, gangrene, septic arthritis or osteomyelitis
- •9.Subjects with rapidly fatal underlying disease not expected to survive to complete the study
- •10.Subjects who have recent history of bone marrow transplant
研究者
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