EUCTR2004-001662-41-LT进行中（未招募）不适用
A Phase III, Randomized, Double-Blind Study of Ceftobiprole versus Vancomycin in the Treatment of Complicated Skin and Skin Structure Infections - NA
Basilea Pharmaceutica Ltd0 个研究点目标入组 700 人开始时间: 2004年10月11日最近更新:
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
- 入组人数
- 700
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
- •1)Written informed consent provided.
- •2)Male or female patients aged = 18 years.
- •3)Patients who, in the opinion of the investigator, require antibiotic therapy with anti-MRSA antibiotic activity.
- •4)Diagnosis of an infection consistent with cSSSI (defined as infections either involving deeper soft tissue or requiring significant surgical intervention) and one or more of the following:
- •a)Infection site within 30 days of surgery/trauma (including partial thickness burns <10% body surface) with purulent drainage from the lesion OR AT LEAST THREE of the following signs:ofever (> 38°C rectal or > 37.5°C oral or > 38.5°C tympanic in the absence of anti-pyretics),
- •olocalized swelling,
- •olocalized erythema extending =10mm beyond wound edge,
- •olocalized pain,
- •otenderness to palpation
- •b)Onset of an abscess (without open wound) in the 7 days before enrollment with purulent drainage or purulent aspirate and evidence of loculated fluid that requires intervention within 48 hours of enrollment, and with erythema and/or induration of =20 mm diameter, or tenderness.
- •c)Onset of cellulitis in the 7 days before enrollment with advancing edema, erythema, or induration and one of the following:
- •ofever (> 38°C rectal or > 37.5°C oral or > 38.5°C tympanic in the absence of anti-pyretics) or reported fever in the 3 days before enrollment.
- •owhite blood cell (WBC) count =10 x 109/L, or =10% bands, or association with lymphangitis and adenopathy.
- •5)Suspected or proven infection with Gram-positive pathogen(s) with biological fluid/tissue samples available from infected lesion at baseline for microbiological culture.
- •6)Complications of infection comprising either a requirement for surgical intervention within 48 hours of enrollment, or involvement of subcutaneous tissues.
- •7)Severity of infection requiring hospitalization or prolongation of hospitalization.
- •8)Anticipated survival > 1 month.
- •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) Female patient who are pregnant or lactating.
- •2) Women of childbearing potential unable or unwilling to use an effective method of birth control.
- •3) Known or suspected hypersensitivity to any study medication (including ß-lactam antibiotics such as penicillins or cephalosporins or vancomycin)
- •4) Any known or suspected condition or concurrent treatment contraindicated by the prescribing information for vancomycin.
- •5) Known or suspected severe renal impairment (calculated CrCl < 30 mL/minute, or oliguria < 20 mL/h unresponsive to fluid challenge) or any form of dialysis.See vancomycin prescribing information in Appendix 4 for dose adjustment in case of reduced CrCl.
- •6) Known or suspected hepatic dysfunction (total bilirubin, or alanine aminotransferase [ALT], or aspartate aminotransferase [AST] = 3 x upper limit of the normal range [ULN])
- •7) Previous enrollment in this study
- •8) Treatment with any investigational drug within 30 days before enrollment
- •9) Any other known or suspected condition of the patient that may jeopardize adherence to protocol requirements.
- •Clinical conditions that may interfere with assessments of efficacy
- •10) Diagnosed or suspected:
- •a) Infection related to a foreign body (e.g., intravascular catheter or prosthetic material) that cannot be removed within 24 hours after enrollment
- •b) endocarditis
- •c) osteomyelitis (sternotomy allowed, if infection is unlikely to extend into the mediastinum)
- •d) septic arthritis
- •e) toxic shock syndrome or shock.
- •11) Inability to start required interventions within 48 hours of enrollment (such as drainage or aspiration, suture removal, first debridement of tissue)
- •12) Super-infected eczema or neoplasia, decubitus ulcers, ischemic wounds where vascular supply is insufficient to allow wound healing
- •13) Neutropenic patients (absolute neutrophil count [ANC] = 0.5 x 109/L) or patients with CD4 counts =0.2 x 109/L.
- •Microbiological conditions that may interfere with assessment of efficacy:
- •14) Systemic antimicrobial therapy > 24 hours in the 7 days before enrollment. Systemic antimicrobial therapy for > 24 hours is permitted in case:
- •a) The infection is caused by microbiologically-confirmed pathogens that are resistant to the previous antimicrobial agents
- •b) The patient is clinically worsening despite at least 72 hours of treatment
- •15) Presence prior to study start of a pathogen known (or expected) to be resistant to either study drug
- •16) Suspected mixed infections that require treatment with medication other than the approved study medication
- •17) Self-limited infections such as isolated folliculitis or furuncules, furunculosis or carbunculosis not associated with cellulitis, or other infection that have a high cure rate after surgery alone.
- •18) Infections presumed at enrollment to be caused by Gram-negative pathogen(s) or mixed anaerobic/aerobic infections, such as:
- •a) decubitus ulcers, episiotomy infection, peri-anal cellulitis, Fournier’s gangrene
- •b) diabetic foot infections
- •c) infections due to animal or human bites
- •d) wound infections after surgical procedures where there is a high probability of Gram-negative pathogen(s), e.g,, if the infection extends to the oropharyngeal, gastrointestinal, urogenital or gynecological tract.
研究者
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