Optimization of Tuberculosis Intradermal Skin Test: TB Dermatest WP 3.1
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- hypersensitivity reaction to tuberculin measured in millimeters of skin induration by comparing two methods of intradermal injection (Mantoux and BD micro-needle). [Phase 1]
研究概览
简要总结
The only test available for in vivo diagnosis of tuberculosis is the intradermal injection of tuberculin according to the Mantoux method (also named tuberculosis skin test or PPD skin test).
The tuberculin skin test is based on a delayed-type hypersensitivity skin reaction However, this test needs to be performed by trained personnel, presents problem of reproducibility, and its interpretation is not well standardized (measure in millimeters of skin induration 48 to 72 hours after the PPD skin test).
The new generation BD micro needle used in this study should solve the technical difficulties; intradermal administration of tuberculin could then be made by any personnel.
A non-invasive and objective instrumental method of reading the test will be also tested .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Subject aged 18 years or over
- •Tuberculosis skin test (PPD)
- •positive : 5mm =<PPD<15mm (24 subjects)
- •negative: PPD < 5mm (6 subjects)
- •Negative Quantiferon test.
- •Legal capacity to consent
- •Subject had given written consent before his participation
- •Subject accepting to participate in the second phase of the study with skin biopsies (24 subjects with positive PPD)
- •Females of childbearing potential using an effective method of contraception, for at least 1 month before the beginning of the study and until 1 month after the end of their participation
排除标准
- •Known allergy to tuberculin
- •History of severe skin reaction to tuberculin with vesicle, ulceration, necrosis
- •History of active tuberculosis
- •Latent tuberculosis (positive Quantiferon test)
- •Contact with a person having or having had active tuberculosis in the previous 3 months
- •Chronic disease non-stabilized under treatment
- •Immunosuppressive therapy or corticosteroids within 1 month before PPD skin tests
- •Non-steroid anti-inflammatory drugs within 1 week before PPD skin tests
- •Application on study areas of topical drugs containing corticoids or immunosuppressants within 1 week before PPD skin test
- •Dermatological disease on study area
- •Known allergy to local anesthetics
- •Wound healing disorders
- •Subject in an exclusion period or participating or planning to participate in another biomedical research
研究组 & 干预措施
Medical device : micro-needle BD 1.5 mm 30G
干预措施: Medical device : micro-needle BD 1.5 mm 30G drug:Tubertest® : tuberculin (purified protein derivative) (Device)
Manthoux method: lance 26G X 16mm
干预措施: medical device: lance 26G X 16mm drug: Tubertest® : tuberculin (purified protein derivative) (Device)
结局指标
主要结局
hypersensitivity reaction to tuberculin measured in millimeters of skin induration by comparing two methods of intradermal injection (Mantoux and BD micro-needle). [Phase 1]
时间窗: 72 h
次要结局
- spectroscopy instrumentation(non-invasive and objective method)to measure the PPD reaction(72 h)
- define changes in the cutaneous immune system at various times (7h, 24h and 48 h), induced by intradermal microinjection of tuberculin, by histological, immunohistochemical and molecular analysis(48 h)