Improving the Sensitivity of Teicoplanin Allergy Testing by Using Autologous Serum
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Does using autologous serum for skin testing yield more positive results as compared to using standard protocol of Teicoplanin Allergy skin test?
研究概览
简要总结
Allergy testing for Teicoplanin is much more unreliable than for other similar drugs. This means that we run the risk of missing serious Teicoplanin allergy, and these patients will be given another dose in future, not knowing that they are seriously allergic. Serious allergic reactions, also known as anaphylaxis, can be life threatening.
The patients which we recruit to our study will come to us through the perioperative allergy service. They will have had a reaction to a general anaesthetic, but will also have had teicoplanin as part of the anaesthetic.
We are not sure why allergy skin testing, which is fairly reliable for most other drugs, is so unreliable in detecting teicoplanin allergy. We do know that some drugs need to mix with proteins in the blood before they trigger an allergy. We would like to replicate this by mixing the teicoplanin with the patients' own blood and using this for the skin testing, to see if we get a more reliable result compared with the plain drug. Using the patient's own serum to do skin testing is an established test (the 'autologous serum test') used in certain immunological conditions, we are simply going to use it as a vehicle to test our theory.
We will recruit 20 adult patients referred with a recent history of anaphylaxis under anaesthesia, where teicoplanin has been given and is one of the drugs under suspicion of having caused the allergy. In addition to the usual allergy skin testing, which would be done anyway as part of standard allergy investigation, we will perform extra tests using autologous serum for this trial.
We hope to find a better way of testing for Teicoplanin allergy, so that patients are not put at risk where the allergy has been missed because of an unreliable test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients 18 years old and above who have suffered suspected anaphylaxis under anaesthesia (the 'index episode'), where teicoplanin has been given
排除标准
- •Patients unable to stop drugs that would interfere with skin tests prior to study- e.g. antihistamines or certain anti-psychotics
- •Pregnancy
- •Patients under age 18 years
- •Patients with elevated baseline mast cell tryptase requiring further investigation
- •Patients with blood-borne viruses such as Hep B, C and HIV
研究组 & 干预措施
Teicoplanin allergy testing using autologous serum
20 adult patients with history of anaphylaxis under anaesthesia ( the index episode), where teicoplanin has been given during the index episode will be recruited. In addition to usual skin testing with Teicoplanin directly onto the skin, we will perform skin testing with Teicoplanin- added autologous serum. The trial will be conducted as part of the same routine elective allergy skin-testing appointment for other drugs given during the index episode.
干预措施: Teicoplanin Allergy Testing using autologous serum (Diagnostic Test)
结局指标
主要结局
Does using autologous serum for skin testing yield more positive results as compared to using standard protocol of Teicoplanin Allergy skin test?
时间窗: 2 years
We will determine if testing using autologous serum for skin testing yield more positive results as compared to using standard protocol of Teicoplanin Allergy test. A positive skin prick test is defined as having wheals of 3x3mm or more at 15 mins. A positive intradermal test results is defined as wheal increment by 3mm in any direction after 20 minutes.
次要结局
未报告次要终点