ISRCTN34716921已完成不适用
A randomised controlled trial of prophylactic antibiotics for the prevention of recurrent cellulitis (erysipelas) of the leg (PATCH I)
niversity of Nottingham (UK)0 个研究点目标入组 260 人开始时间: 2006年5月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 260
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged over 16 years - no upper age limit, either sex
- •2. At least one previous episode of cellulitis of either leg within the three years prior to the current acute index episode of cellulitis.
排除标准
- •Added 09/01/2009:
- •Any doubt about the certainty of the diagnosis of either the index episode or the previous episode (if applicable), will be grounds for exclusion. Additionally, patients with any of the following will be excluded:
- •1. Taken antibiotic prophylaxis (defined as more than 3 months usage) for the prevention of cellulitis within 6 months prior to index episode
- •2. A time lapse of longer than 12 weeks since the start of treatment for the index episode to the date of potential randomisation into the trial
- •3. Known allergy to penicillin
- •4. Preceding leg ulceration, surgery or penetrating trauma, as these cases are more likely to be caused by staphylococcal infection. (NB: this does not exclude patients with toeweb maceration/tinea pedis or other minor/blunt wounds)
- •5. Treating physician or principal investigator unwilling to randomise patient. This includes, but is not limited to:
- •5.1. The treating physician and/or patient feels that prophylactic antibiotics are not in the patient's best interests and therefore entry to this study would be inappropriate
- •5.2. The treating physician and/or patient feels it would not be ethical or appropriate for the patient to receive placebo and so they are not willing/able to accept randomisation
- •5.3. Concomitant medication that would mean that long-term penicillin is inappropriate
- •5.4. Diagnostic uncertainty
- •5.5. Gastrointestinal disease causing persistent diarrhoea or vomiting severe enough to affect the absorption of the phenoxymethylpenicillin
- •5.6. Allergic diathesis or severe bronchial asthma severe enough to preclude the use of phenoxymethylpenicillin
- •5.7. Confounding concurrent disease (e.g. deep vein thrombosis [DVT])
- •6. No access to a telephone
- •7. Aged less than 16 years
- •8. Unable to give informed consent
- •9. Already taking part in a research study
研究者
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