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Optimization of Tuberculosis Intradermal Skin Test

NCT01611844 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2025-09-03

No results posted yet for this study

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 .

Conditions

  • Healthy Volunteers

Interventions

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

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

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Principal Investigators

  • Catherine GOUJON, MD · Centre Hospitalier Lyon Sud -Hospices Civils de Lyon

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2012-06-30
Completion
2013-04-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01611844 on ClinicalTrials.gov