EUCTR2008-006151-42-IE进行中（未招募）不适用
A comparison of oral flucloxacillin alone with combined oral phenoxymethylpenicillin and flucloxacillin for the treatment of uncomplicated skin and soft tissue infections
Beaumont Hospital0 个研究点开始时间: 2008年12月10日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •It is intended to carry out a Phase IV, double blinded, placebo controlled, prospective randomised controlled trial comparing the two treatment arms on patients attending the emergency department of Beaumont Hospital Dublin.
- •It is intended to obtain written informed consent from each patient before enrolment.
- •In patient s between the ages of 12 and 16 years of age, it is intended to obtain consent from parent / next of kin.
- •Eligible patients will include those aged >12 years of age with uncomplicated skin and / or skin structure infections that can be treated with antibiotics for a period of 7-10 days.
- •These infections may include, but are not limited to, the following clinical descriptors:
- •Simple Abscess
- •Wound infection
- •Furunculosis
- •Folliculitis
- •Inclusion criteria
- •>12 years of age
- •Skin infection +/- skin structure infection that is treatable with oral antibiotic
- •Any 2 of the following signs
- •erythema / warmth / tenderness / swelling / purulent drainage or discharge / regional lymphadenopathy / induration
- •Women of childbearing potential will be requested to submit a pretrial urinary pregnancy test, and agree to use effective contraception throughout the study.
- •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
- •Exlusion criteria
- •Chronic skin condition at the site of infection
- •Infection involving prosthetic material
- •Thermal injury
- •Acne vulgaris
- •Perirectal abscess / cellulitis (high risk of anaerobic infection)
- •Fungal infection of scalp or nail bed
- •Suspected bacteraemia
- •Infection severe enough to require intravenous antibiotic
- •Immunodeficiency
- •Significant vascular disease at the site of infection
- •Concomitant treatment with oral or parenteral or topical antibiotics at infection site
- •Hypersensitivity to penicillin
- •Use of any systemic antibiotic within 7 days
- •Patients taking systemic corticosteroids at a dose exceeding 15 mg (or equivalent) per day for greater than 7 days
研究者
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