NCT00828971已完成3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 16
- 主要终点
- Clinical response up to 14-21 days after the completion of study drug therapy (Test-of-Cure visit [TOC]).
研究概览
简要总结
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
- •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)
- •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
排除标准
- •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
研究组 & 干预措施
Arm 1
Experimental
干预措施: Avelox (Moxifloxacin, BAY12-8039) (Drug)
Arm 2
Active Comparator
干预措施: Amoxicilline/clavulanic (Drug)
结局指标
主要结局
Clinical response up to 14-21 days after the completion of study drug therapy (Test-of-Cure visit [TOC]).
时间窗: Test-of-Cure visit [TOC].
次要结局
- Clinical response assessed by the investigator at the end-of-therapy (EOT).(At the end-of-therapy (EOT))
- Time to switch from oral to IV therapy(Day of switch from oral to IV therapy)
- Bacteriological response (for microbiologically valid population) at the EOT and TOC(At the end-of-therapy (EOT), Test-of-Cure visit [TOC].)
- Clinical response assessed by the investigator on treatment Day 3-5(Day 3-5)
研究者
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