NCT00087490已完成4 期
Linezolid 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
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 1,077
- 试验地点
- 127
- 主要终点
- Clinical Outcome in Participants With Baseline Methicillin-Resistant Staphylococcus Aureus (MRSA) at End of Study (EOS) for Per-Protocol (PP) Population
研究概览
简要总结
To determine if linezolid is superior to vancomycin in the treatment of complicated skin and soft tissue infections due to MRSA in adult subjects
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
- None
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
- •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).
- •Signs and symptoms consistent with infection
- •Infection suspected to be due to Methicillin Resistant Staphylococcus Aureus
排除标准
- •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).
- •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.
- •Subjects excluded with necrotizing fasciitis, gas gangrene, osteomyelitis
结局指标
主要结局
Clinical Outcome in Participants With Baseline Methicillin-Resistant Staphylococcus Aureus (MRSA) at End of Study (EOS) for Per-Protocol (PP) Population
时间窗: EOS (6 to 28 days after the last dose of study drug)
Clinical response (CR) was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation time point. At EOS, CR was evaluated as "success" (cure: resolution of clinical signs or (/) symptoms of infection when compared to baseline); "failure": persistence/progression of baseline signs/symptoms of infection after at least 2 days of treatment/development of new clinical findings consistent with active infection; "unknown": extenuating circumstances precluding classification to 1 of above. "Unknown" was excluded from present analysis.
次要结局
- Clinical Outcome in Participants With Baseline MRSA at End of Treatment (EOT) for PP Population(EOT (within 72 hours of last dose of study drug))
- Clinical Outcome in Participants With Baseline MRSA at EOS for Modified-Intent to Treat (mITT) Population(EOS (6 to 28 days after the last dose of study drug))
- Clinical Outcome in Participants With Baseline MRSA at EOT for mITT Population(EOT (within 72 hours of last dose of study drug))
- Microbiological Outcome in Participants With Baseline MRSA at EOS for PP Population(EOS (6 to 28 days after the last dose of study drug))
- Microbiological Outcome in Participants With Baseline MRSA at EOT for PP Population(EOT (within 72 hours of last dose of study drug))
- Microbiological Outcome in Participants With Baseline MRSA at EOS for mITT Population(EOS (6 to 28 days after the last dose of study drug))
- Microbiological Outcome in Participants With Baseline MRSA at EOT for mITT Population(EOT (within 72 hours of last dose of study drug))
- Number of Participants With Clinical Signs and Symptoms at EOT and EOS for PP Population(EOT (within 72 hours of last dose of study drug), EOS (6 to 28 days after the last dose of study drug))
- Number of Participants With Clinical Signs and Symptoms at EOT and EOS for mITT Population(EOT (within 72 hours of last dose of study drug), EOS (6 to 28 days after the last dose of study drug))
- Duration of Hospital Stay for PP Population(Baseline up to EOS (6 to 28 days after the last dose of study drug))
- Duration of Hospital Stay for mITT Population(Baseline up to EOS (6 to 28 days after the last dose of study drug))
- Duration of Intravenous Therapy for PP Population(Baseline up to EOS (6 to 28 days after the last dose of study drug))
- Duration of Intravenous Therapy for mITT Population(Baseline up to EOS (6 to 28 days after the last dose of study drug))
- Number of Participants Using Medical Resources(Baseline up to EOS (6 to 28 days after the last dose of study drug))
研究者
研究点 (127)
Loading locations...
相似试验
已完成
4 期
Nosocomial Pneumonia With Suspected Or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA)Methicillin Resistant Staphylococcus Aureus (MRSA)NCT00084266Pfizer1,225
已完成
3 期
Antibiotic Treatment for Infections of Short Term In-dwelling Vascular Catheters Due to Gram Positive BacteriaBacterial InfectionsGram-Positive Bacterial InfectionsBacteremiaNCT00037050Pfizer739
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 AureusLinezolid en el tratamiento de infecciones complicadas de piel y partes blandas causadas por Staphylococcus aureus resistente a meticilinaComplicated skin and soft tissue infectionsClassification code 10049582EUCTR2004-001200-12-ESPfizer,S.A.1,200
进行中（未招募）
不适用
inezolid In The Treatment Of Complicated Skin And Soft Tissue Infections Proven To Be Due To Methicillin-Resistant Staphylococcus Aureus - N/AComplicated skin and soft tissue infectionsClassification code 10049582EUCTR2004-001200-12-BEPfizer Global Research and Development1,200
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 AureusEUCTR2004-001200-12-IEPfizer Global Research and Development1,200