A Double Blind Randomised Control Trial to Measure the Effect of the Addition of Clindamycin to Flucloxacillin for the Treatment of Limb Cellulitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 410
- 试验地点
- 1
- 主要终点
- Improvement based on a composite of systemic and local features
研究概览
简要总结
The aim of this study is to see whether the addition of Clindamycin, a protein inhibiting antibiotic, to the standard antibiotic treatment of limb cellulitis, with Flucloxacillin, results in less tissue damage and a more rapid resolution of both systemic and local features, in a cost-effective manner. This study is a randomised controlled trial comparing Clindamycin with placebo.
详细描述
Criteria to be used to assess tissue damage and clinical response:
- Fever, tachycardia, neutrophil count, urea and other laboratory parameters at five and ten days post first dose of clindamycin
- Limb swelling (by the measurement of limb circumference), skin surface temperature and tissue damage (by the proportion of the limb affected)
- Document the duration between initial systemic features and the development of local signs
- Examine the effect of the duration between systemic and local features and first dose of flucloxacillin on the subsequent duration and severity of cellulitis
- Examine the effect of duration between the first dose of flucloxacillin and the first dose of clindamycin on the subsequent duration and severity of cellulitis
- Identify and quantify possible side effects of clindamycin
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 or female subjects aged 18 or over who have a diagnosis of cellulitis of a single, upper or lower, limb
- •Who are able to understand the study and give consent
- •Who are able to take oral medication
排除标准
- •Patients with a confirmed history of penicillin, flucloxacillin or clindamycin allergy
- •Patients known to be colonised with Methicillin-resistant Staphylococcus aureus or Methicillin-resistant Staphylococcus aureus isolated from wound within the last year
- •Patients unable to take oral medication
- •Previous history of Clostridium difficile colitis
- •Clindamycin taken within the last 30 days
- •Clinically unstable
- •Unable to understand the study or give consent
- •Any doubt over the certainty of the diagnosis of cellulitis
- •Patients taking any drug that is incompatible with either flucloxacillin or clindamycin
- •Pre-existing diarrhoea
研究组 & 干预措施
Flucloxacillin and Placebo oral capsule
Intravenous or oral Flucloxacillin with a Placebo oral capsule
干预措施: Flucloxacillin (Drug)
Flucloxacillin and Placebo oral capsule
Intravenous or oral Flucloxacillin with a Placebo oral capsule
干预措施: Placebo oral capsule (Drug)
Flucloxacillin and Clindamycin
Intravenous or oral Flucloxacillin with Clindamycin oral capsule
干预措施: Flucloxacillin (Drug)
Flucloxacillin and Clindamycin
Intravenous or oral Flucloxacillin with Clindamycin oral capsule
干预措施: Clindamycin (Drug)
结局指标
主要结局
Improvement based on a composite of systemic and local features
时间窗: Day 5
Temperature less than 37.5 degrees centigrade, reduction in limb swelling and reduction in skin temperature
次要结局
- Decrease in pain(Day 10)
- Quality of life(Day 30)
- Physiological recovery(Day 10)