EUCTR2011-004013-16-BG进行中（未招募）不适用
A Phase III, Multicentre, Randomised, Double-Blind, Comparative Study to Evaluate the Efficacy and Safety of Ceftaroline Fosamil (600mg every 8 hours) Versus Vancomycin Plus Aztreonam in the Treatment of Patients With Complicated Bacterial Skin and soft Tissue Infections With Evidence of Systemic Inflammatory Response or Underlying Comorbidities - Ceftaroline Fosamil cSSTI
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 825
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. Patient must provide a signed written informed consent prior to any study-specific procedures
- •2. Patient must be a male or female, aged 18 years and older
- •3. Patient must have one of the following cSSTIs:
- •- Cellulitis: a diffuse skin infection characterised by spreading areas of erythema, oedema, and/or induration of a minimum surface area of 75 cm2 (eg, minimum length of 10 cm and width of 7.5 cm)
- •- Traumatic or surgical wound infection: an infection characterised by purulent drainage/or collection from an injury-related wound or a surgical wound with surrounding erythema, oedema, and/or induration of a minimum surface area of 75 cm2 (eg, the shortest distance of redness, oedema, and/or induration extending at least 5 cm from the peripheral margin of the wound). Appropriate surgical intervention must be completed prior to the first dose of study drug or up to, at most, 48 hours after the first dose of study drug.
- •NOTE: In some cases the shortest distance of redness, oedema, and/or induration extends less than 5 cm from the peripheral margin of the wound/abscess/ burn infection. However, if the surface area of infection is at least 75 cm2, then the patient will be eligible. Please refer to the Wound Measurement Guidelines for further clarification.
- •- Major cutaneous abscess: an infection characterised by a collection of pus within the dermis or deeper that is accompanied by erythema, oedema, and/or induration of a minimum surface area of 75 cm2 (eg, the shortest distance of redness, oedema, and/or induration extending at least 5 cm from the peripheral margin of the abscess). The abscess must undergo incision and drainage prior to the first dose of study drug or up to, at most, 48 hours after the first dose of study drug. The number of patients with major cutaneous abscesses will be limited to no more than30% of the study population.
- •- Burn infection: an infection characterised by purulent drainage, erythema, oedema, and/or induration of a minimum surface area of 75 cm2 (eg, the shortest distance of redness, oedema, and/or induration extending at least 5 cm from the peripheral margin of the burn infection). Burns must involve less than 15% of the body surface area and acquired within 7 days of hospitalisation. Appropriate surgical intervention must be completed prior to the first dose of study drug or up to, at most, 48 hours after the first dose of study drug.
- •4. (N/A for MRSA expansion period)Patients must demonstrate at least one of the following criteria (for the first 3 bullets, the criterion must be met within 24 hours prior to first dose of study drug):
- •- Temperature =38.0°C (100.4°F) or =36.0°C (96.8°F)
- •- White blood cells >12000 cells/mm3 or <4000 cells/mm3 or >10% band forms
- •(immature white blood cells)
- •- Heart rate >90 beats per minute and respiratory rate >20 breaths per minute after
- •10 minutes of rest
- •- One or more of the following comorbidities:
- •- Diabetes mellitus requiring drug therapy (note: patients with diabetic foot infections are excluded as per exclusion criterion #8)
- •- Stage 2 or 3 HIV infection (per Center for Disease control classification 2008) (note: patients with a CD4 count <150 cell/microliter within 6 months prior to first dose of study drug or suspected opportunistic infection are excluded)
- •- Chronic renal impairment (estimated creatinine clearance =20 mL/min to <50 mL/min) as calculated by the Cockcroft-Gault formula
- •- Cirrhosis with Child-Pugh Stage A or B (
排除标准
- •. Received systemic antibacterial drugs for greater than 24 hours within 96 hours prior to first dose of study drug(Note that for MRSA expansion period patients are only to be excluded if they have received systemic drugs that are active against MRSA for > 24 hrs within the 96 hours prior to first dose of study drug)
- •. Uncomplicated skin and skin structure infections, skin infections suspected to be caused by viral or fungal pathogens
- •. Diabetes, diabetic foot infections, decubitus ulcers, ulcers due to peripheral vascular disease
- •. Infection caused by human bites, sternal wound infections, bone infection or arthritis due to an infection, critical limb ischemia of the affected limb
- •. Chronic liver disease or severe impaired renal function, severe low white blood cell count, burns on greater than 15% of total body surface area, necrotizing skin infection, amputation required of primary site of infection, sustained shock
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