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Optimization of Tuberculosis Intradermal Skin Test (TB Dermatest)

Primary Purpose

Healthy Volunteers

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Medical device : micro-needle BD 1.5 mm 30G drug:Tubertest® : tuberculin (purified protein derivative)
medical device: lance 26G X 16mm drug: Tubertest® : tuberculin (purified protein derivative)
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Healthy Volunteers focused on measuring delayed-type hypersensitivity reaction to tuberculin intradermal injection, tuberculosis skin test, BD micro-needle, medical device, spectroscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • 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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Medical device : micro-needle BD 1.5 mm 30G

Manthoux method: lance 26G X 16mm

Arm Description

Outcomes

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]

Secondary Outcome Measures

spectroscopy instrumentation(non-invasive and objective method)to measure the PPD reaction
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

Full Information

First Posted
December 22, 2011
Last Updated
July 30, 2013
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT01611844
Brief Title
Optimization of Tuberculosis Intradermal Skin Test
Acronym
TB Dermatest
Official Title
Optimization of Tuberculosis Intradermal Skin Test: TB Dermatest WP 3.1
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers
Keywords
delayed-type hypersensitivity reaction to tuberculin intradermal injection, tuberculosis skin test, BD micro-needle, medical device, spectroscopy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Medical device : micro-needle BD 1.5 mm 30G
Arm Type
Experimental
Arm Title
Manthoux method: lance 26G X 16mm
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Medical device : micro-needle BD 1.5 mm 30G drug:Tubertest® : tuberculin (purified protein derivative)
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
medical device: lance 26G X 16mm drug: Tubertest® : tuberculin (purified protein derivative)
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
spectroscopy instrumentation(non-invasive and objective method)to measure the PPD reaction
Time Frame
72 h
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine GOUJON, MD
Organizational Affiliation
Centre Hospitalier Lyon Sud -Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
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
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France

12. IPD Sharing Statement

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Optimization of Tuberculosis Intradermal Skin Test

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