A Study to Assess Efficacy and Safety of IV/PO Moxifloxacin in the Treatment of cSSSIs (MERAK)
2014年12月5日 更新者：Bayer
A Prospective, Randomized, Open Label, Active Comparator, Multicenter, National Trial to Compare the Efficacy and Safety of Sequential IV/PO Moxifloxacin 400 mg Once Daily Versus IV Amoxicillin/Clavulanate 2,0/0,2 g Every 8 Hours Followed by Oral Amoxicillin/Clavulanate 875/125 mg Every 8 Hours in the Treatment of Adult Subjects With Complicated Skin and Skin Structure Infections
The purpose of this study is to assess if a therapy with intravenous and oral moxifloxacin is as effective as a therapy with intravenous and oral amoxicilline/clavulanate in the treatment of complicated skin and skin structure infection.
研究概览
研究类型
介入性
注册 (实际的)
16
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Bari、意大利、70124
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Bergamo、意大利、24128
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Bologna、意大利、40138
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Brescia、意大利、25123
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Ferrara、意大利、44100
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Firenze、意大利、50139
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Foggia、意大利、71100
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Genova、意大利、16132
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Mantova、意大利、46100
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Messina、意大利、98158
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Napoli、意大利、80131
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Padova、意大利、35128
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Perugia、意大利、06122
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Reggio Emilia、意大利、42100
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Rimini、意大利、47900
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Roma、意大利、00149
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Roma、意大利、00168
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Torino、意大利、10149
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Udine、意大利、33100
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Varese、意大利、21100
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Verona、意大利、37126
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Firenze
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Bagno di Ripoli、Firenze、意大利、50100
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Written informed consent
Men or women of age >/= 18 years with a diagnosis of bacterial skin and skin structure infection that requires
- Hospitalization
- Initial parenteral therapy for at least 48 hours
Complicated by at least one of the following criteria:
- Involvement of deep soft tissues (e.g. fascial, muscle layers)
- Requirement for a significant surgical intervention including surgical drainage, drainage procedure guided by imaging and/or debridement
- Association with a significant underlying disease that may complicate response to treatment.
- Presence of SIRS (Systemic Inflammatory Response Syndrome) defined as two or more of the following signs or symptoms: - temperature > 38.3°C or < 36°C - white blood cell count > 12.000/mmc or < 4.000 or > 10% bands - pulse rate > 90 beats/min - respiratory rate > 20178 - systolic blood pressure </= 90 mmgHg - decreased capillary refill/mottling > 2 seconds - lactate > 2 mmol/L - altered mental status - hyperglycemia > 120 mg/dl or 7.7 mmol/L in the absence of diabetes - protein C (CPR) > 20 mg/L (VR 0-5)3. Duration of infection < 21 days
Diagnosis of one of the following skin and skin structure infections:
- major abscess(es) associates with extensive cellulitis
- erysipelas and cellulitis
- infected pressure ulcers(s)
- wound infections including: post surgical (surgical incision), post traumatic, human bite/clenched fist and animal bite wound and wound associated with injection drug abuse
- Infected ischemic ulcers with at least one of the following conditions: - Diabetes mellitus - Peripheral vascular disease - Conditions pre-disposing to pressure scores such as paraplegia or peripheral neuropathy
Presence of at least 3 of the following local signs and symptoms
- purulent drainage or discharge
- erythema extended >1 cm from the wound edge
- fluctuance
- pain or tenderness to palpation
- swelling or induration
- fever defined as body temperature > 37.5°C (axillary), > 38°C (orally), > 38.5°C (tympanically), or > 39°C (rectally). OR Elevated total peripheral white blood cell (WBC) count> 12,000/mm3 OR > 15% immature neutrophils (blends) regardless of total peripheral WBC count
- C-reactive protein (CRP) >20 mg/L
Exclusion Criteria:
- Women, who are pregnant or lactating, or in whom pregnancy can not be excluded (Note: a urine pregnancy test has to be performed for all women of childbearing potential before randomization to the study drug).
The following skin and skin structure infections:
- Necrotizing fasciitis including Fournier's gangrene, ecthyma gangrenosum, streptococcal necrotizing fasciitis and clostridial necrotizing fasciitis.
- Burn wound infections.
- Secondary infections of a chronic skin disease (eg, atopic dermatitis).
- Infection of prosthetic materials. Subjects with removal of a prosthetic device involved in an infection should not be included.
- Infections where a surgical procedure alone is definitive therapy.
- Subjects with uncomplicated skin and skin structure infections including
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：手臂 2
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IV Amoxicilline/clavulanic acid 2000/200 mg TID followed by PO amoxicilline/clavulanate 875/125 mg TID for a total of 7 to 21 days
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实验性的：手臂 1
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Sequential IV/PO moxifloxacin 400/400 mg every 24 hours, for 7 to 21 days.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Clinical response up to 14-21 days after the completion of study drug therapy (Test-of-Cure visit [TOC]).
大体时间：Test-of-Cure visit [TOC].
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Test-of-Cure visit [TOC].
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Clinical response assessed by the investigator on treatment Day 3-5
大体时间：Day 3-5
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Day 3-5
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Clinical response assessed by the investigator at the end-of-therapy (EOT).
大体时间：At the end-of-therapy (EOT)
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At the end-of-therapy (EOT)
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Time to switch from oral to IV therapy
大体时间：Day of switch from oral to IV therapy
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Day of switch from oral to IV therapy
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Bacteriological response (for microbiologically valid population) at the EOT and TOC
大体时间：At the end-of-therapy (EOT), Test-of-Cure visit [TOC].
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At the end-of-therapy (EOT), Test-of-Cure visit [TOC].
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2008年11月1日
初级完成 (实际的)
2009年9月1日
研究完成 (实际的)
2009年10月1日
研究注册日期
首次提交
2009年1月23日
首先提交符合 QC 标准的
2009年1月23日
首次发布 (估计)
2009年1月26日
研究记录更新
最后更新发布 (估计)
2014年12月8日
上次提交的符合 QC 标准的更新
2014年12月5日
最后验证
2014年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.