Optimization of Tuberculosis Intradermal Skin Test

Healthy Volunteers Clinical Trial

— TB Dermatest  

Official title:

Optimization of Tuberculosis Intradermal Skin Test: TB Dermatest WP 3.1

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01611844
• Other study ID #: 2009.591
• Status: Completed
• Phase: N/A
• First received: December 22, 2011
• Last updated: July 30, 2013
• Start date: September 2011
• Est. completion date: April 2013

Study information

• Verified date: July 2013
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: April 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Healthy Volunteers
• Tuberculosis

Intervention

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

Locations

Country	Name	City	State
France	Unité de Recherche Clinique en Immunologie Lyon Sud (URCI-LS) et Service d'Immunologie clinique et allergologie-Centre Hospitalier Lyon Sud -Hospices Civils de Lyon	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	spectroscopy instrumentation(non-invasive and objective method)to measure the PPD reaction		72 h	No
Secondary	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	No