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Optimization of Tuberculosis Intradermal Skin Test (TB Dermatest)

This study is currently recruiting participants.
Verified May 2012 by Hospices Civils de Lyon
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01611844
First received: December 22, 2011
Last updated: May 31, 2012
Last verified: May 2012
History of Changes
  Purpose

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 .


Condition Intervention
Healthy Volunteers
 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)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Optimization of Tuberculosis Intradermal Skin Test: TB Dermatest WP 3.1

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • hypersensitivity reaction to tuberculin measured in millimeters of skin induration by comparing two methods of intradermal injection (Mantoux and BD micro-needle). [Phase 1] [ Time Frame: 72 h ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • spectroscopy instrumentation(non-invasive and objective method)to measure the PPD reaction [ Time Frame: 72 h ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 48 h ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Medical device : micro-needle BD 1.5 mm 30G 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
Active Comparator: Manthoux method: lance 26G X 16mm Device: 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01611844

Contacts
Contact: Catherine GOUJON, MD +33 478 86 41 25 catherine.goujon@chu-lyon.fr

Locations
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 Recruiting
Pierre-Bénite, France, 69495
Contact: Catherine GOUJON, MD     +33 478 86 41 25     catherine.goujon@chu-lyon.fr    
Principal Investigator: Catherine GOUJON, MD            
Sub-Investigator: Sophie GRANDE, MD            
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Catherine GOUJON, MD Centre Hospitalier Lyon Sud -Hospices Civils de Lyon
  More Information

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01611844     History of Changes
Other Study ID Numbers: 2009.591
Study First Received: December 22, 2011
Last Updated: May 31, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:
delayed-type hypersensitivity reaction to tuberculin intradermal injection
tuberculosis skin test
BD micro-needle
medical device
spectroscopy

Additional relevant MeSH terms:
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on May 23, 2013