EUCTR2004-001200-12-IT进行中（未招募）不适用
INEZOLID IN THE TREATMENT OF SUBJECTS WITH COMPLICATED SKIN AND SOFT TISSUE INFECTIONS PROVEN TO BE DUE TO METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- PFIZER
- 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
- •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 the process of referral to a hospital at the time of randomization. 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 or pain local warmth
- •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. 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 than linezolid or vancomycin for more than 24 hours and treatment extended into the 72 hour 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 7. Subjects who were treated with linezolid or vancomycin for more than 24 hours and treatment extended into the 72 hour period prior to the first dose of study drug. Subjects who were treated with linezolid or vancomycin for the infection under study prior to this timeframe may be enrolled unless they received 72 hours or more of treatment and did not respond. 8. Subjects with known or suspected necrotizing fasciitis, gas gangrene, gangrene, septic arthritis or osteomyelitis. 9. Subjects with an infection involving a limb with evidence of critical ischemia in the affected limb defined as any of the following criteria Absent or abnormal Doppler wave forms Toe blood pressure of 45 mm Hg Ankle brachial index of 0.5 Critical ischemia as assessed by a vascular surgeon 10. Subjects with rapidly fatal underlying disease not expected to survive to complete the study. 11. Subjects who have recent history of bone marrow transplant in post-transplant hospital stay . 12. Subject with pheochromocytoma, untreated hyperthyroidism, untreated or uncontrolled hypertension, or carcinoid syndrome. 13. Subject with known or suspected meningitis or endocarditis. 14. Subject who has clinical AIDS or a CD4 cell count 200 cells/mm3 secondary to HIV infection. 15. Subjects with sustained shock, defined as systolic blood pressure 90 mm Hg for 2 hours despite adequate fluid resuscitation, with evidence of hypoperfusion or need for sympathomimetic agents to maintain blood pressure. 16. Subjects who have medical conditions in which inflammation may be prominent for an extended period even after successful bacterial eradication, e.g., superinfected eczema or atopic dermatitis . 17. Subjects with uncomplicated skin or superficial skin structure infection such as superficial/simple cellulitis, impetiginous lesion, furuncle, or simple abscess that only need surgical drainage for cure. 18. Subjects from whom a culture cannot be obtained. 19. Subjects with self-limited infections such as isolated folliculitis or other infection that has a high surgical incision cure rate or furunculosis that is not associated with e
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