A Randomized, Double-blind, Equivalence Study of Tuberculin Purified Protein Derivative in Comparison With a Reference Standard Tuberculin Purified Protein Derivative (PPD-S2) for Detection of Tuberculosis in Subjects With a Confirmed Diagnosis of Tuberculosis.
试验速览
- 阶段
- 2 期
- 入组人数
- 90
- 主要终点
- Compare new PPD to Reference Standard
研究概览
简要总结
A study to determine bioequivalence of PPD material versus Reference Standard.
详细描述
This study is a multicenter, double-blind, active-controlled parallel-group study to determine the bioequivalence of newly produced PPD material versus PPD-S2 in the detection of male and female subjects with current or previously diagnosed intrathoracic Mtb infection, as documented by a positive culture for Mtb (preferred method), by their primary care or attending physician and/or by the subject's current or prior medical records (ie, sensitivity determination).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or nonpregnant females age 18 to 60 years
- •Documented PPD reactivity of 5 to 21 mm in the past, documented in a medical record. Self-reported PPD reactivity will be acc
- •Give written informed consent to participate
- •Generally healthy, as determined by medical history and targeted physical examination, if indicated
- •Possess 2 forearms that are free of burns, scars, eczema, or any physical deformity, which could impair injection of study prepar
- •Comprehension of the study requirements; expressed availability for the required study period, including readings at the nomina
排除标准
- •Prior PPD test within the past 30 days
- •Subject is of childbearing potential and unable to use contraceptives; is planning pregnancy; is pregnant or lactating
- •History of anaphylactic reaction, severe positive tuberculin reaction (eg, ulceration, necrosis) or other severe reaction to PPD in
- •Subject received a Bacillus Calmette-Guérin (BCG) vaccination in the past, or was born or lived outside the US as a child and is
- •Presence of conditions that may suppress TST reactivity -
结局指标
主要结局
Compare new PPD to Reference Standard
时间窗: 72 hours
Determine bio-equivalence of material used in trial by means of dose response and reaction sizes in patients.
次要结局
未报告次要终点
