Optimization of Tuberculosis Intradermal Skin Test (TB Dermatest)

Civil Hospices of Lyon

Status

Completed

Conditions

Healthy Volunteers

Treatments

Device: medical device: lance 26G X 16mm drug: Tubertest® : tuberculin (purified protein derivative)

Device: Medical device : micro-needle BD 1.5 mm 30G drug:Tubertest® : tuberculin (purified protein derivative)

Study type

Interventional

Funder types

Other

Identifiers

NCT01611844

2009.591

Details and patient eligibility

About

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 .

Enrollment

59 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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