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临床试验/NCT01667055
NCT01667055已完成不适用

The Optimized Diagnostic Methods for the Confirmation of Beta-lactam Hypersensitivity in Thailand

Chulalongkorn University1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2012年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
500
试验地点
1
主要终点
The true prevalence of drug allergy in patients with a history of beta-lactam hypersensitivity

研究概览

简要总结

The true prevalence of drug allergy in patients with a history of beta-lactam hypersensitivity will be determined by using commercially available standard skin test reagents and the diagnostic agents available in Thailand. We hypothesize that only minority of patients with such a history are truly allergic.

详细描述

Patients with a history of beta-lactam hypersensitivity will be evaluated by the standard skin test reagents (major and minor determinants of penicillin, amoxicillin, and clavulanic if applicable), and intravenous forms of beta-lactam antibiotics .

Diagnostic values of the measurement of specific Immunoglobulin E to penicillin/aminopenicillin and skin test reagents currently available in Thailand will be comparatively analyzed with the standard skin test reagents.

The measurement of drug-induced interferon-gamma releasing cells will be measured in patients with a history of non-immediate reaction.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
7 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with a history of beta-lactam hypersensitivity

排除标准

  • Being pregnant
  • Having serious medical illnesses

结局指标

主要结局

The true prevalence of drug allergy in patients with a history of beta-lactam hypersensitivity

时间窗: 1 year

The skin test positive rate in patients with a history of beta-lactam hypersensitivity

次要结局

  • Clinical values of various diagnostic modalities in patients with a history of beta-lactam hypersensitivity(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Assoc. Prof. Jettanong Klaewsongkram, MD.

Associate Professor

Chulalongkorn University

研究点 (1)

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