Optimization of Tuberculosis Intradermal Skin Test

Study Overview
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Brief Summary
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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 .

Official Title
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Optimization of Tuberculosis Intradermal Skin Test: TB Dermatest WP 3.1

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Device: Medical device : micro-needle BD 1.5 mm 30G drug:Tubertest® : tuberculin (purified protein derivative)
* Device: medical device: lance 26G X 16mm drug: Tubertest® : tuberculin (purified protein derivative)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medical device : micro-needle BD 1.5 mm 30G<br> | Device: Medical device : micro-needle BD 1.5 mm 30G drug:Tubertest® : tuberculin (purified protein derivative)<br>* 2 intradermal injections are performed on each arm/bottom of the subject: 1 intradermal injection of Tuberculin (5UI) 1 intradermal injection of saline solution using Manthoux method or BD micro-needle. the method of injection is randomized: left or right<br>|
| Active Comparator: Manthoux method: lance 26G X 16mm<br> | Device: medical device: lance 26G X 16mm drug: Tubertest® : tuberculin (purified protein derivative)<br>* 2 intradermal injections are performed on each arm/bottom of the subject: 1 intradermal injection of Tuberculin (5UI) 1 intradermal injection of saline solution using Manthoux method or BD micro-needle. the method of injection is randomized: left or right<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hypersensitivity reaction to tuberculin measured in millimeters of skin induration by comparing two methods of intradermal injection (Mantoux and BD micro-needle). [Phase 1] |  | 72 h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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delayed-type hypersensitivity reaction to tuberculin intradermal injection, tuberculosis skin test, BD micro-needle, medical device, spectroscopy