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临床试验/NCT01798121
NCT01798121Unknown2 期

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.

JHP Pharmaceuticals LLC0 个研究点目标入组 90 人开始时间: 2013年2月最近更新:
适应症

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

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

研究者

申办方类型
Industry
责任方
Sponsor

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