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Comparison of Diagnostic Performance of C-Tb to QuantiFERON®-TB, in Combination With a Safety Assessment of C-Tb vs Tuberculin PPD RT23 SSI

NCT01631266 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 979

Last updated 2015-04-17

No results posted yet for this study

Summary

Tuberculosis (TB) continues to be the most important bacterial infection worldwide and therefore new improved diagnostic tests are needed to help doctors in diagnosing TB.

We are investigating a new skin test named C-Tb. Like the current tuberculin skin test (PPD), the C-Tb test is injected just under the skin and will, when positive, show redness and/or swelling at the injection site while a negative test will leave no reactions.

The aim of this trial is to test the C-Tb skin test in volunteers. The volunteers are divided into four groups:

* Negative control group: Must have no history of exposure to a person with tuberculosis disease.
* Occasional contact: Must be in contact with a person with tuberculosis disease between 6 hours/week and 6 hours/day
* Close contact: Must be in close contact with a person with tuberculosis disease for more than 6 hours/day for at least five days
* Positive control group: Must have a confirmed tuberculosis disease within the last 3 years.

The goals of this clinical trial are:

* To compare the C-Tb test to a blood test, the QuantiFERON test.
* To compare the C-Tb test to the PPD test that is currently being used.
* To assess the safety of the C-Tb test.

Conditions

Interventions

BIOLOGICAL

C-Tb

The C-Tb agent is administered by the Mantoux injection technique to each volunteer in the RIGHT or LEFT forearm according to a double blind randomisation scheme

BIOLOGICAL

2 T.U. Tuberculin PPD RT 23 SSI

The 2 T.U. Tuberculin PPD RT 23 SSI agent is administered by the Mantoux injection technique to each volunteer in the RIGHT or LEFT forearm according to a double blind randomisation scheme

Sponsors & Collaborators

  • Statens Serum Institut

    lead OTHER

Principal Investigators

  • Joan Cayla, MD · Public Health Agency of Barcelona

  • Henrik Aggerbeck, M. Sc. · Statens Serum Institut

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • Spain

Study Locations

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Entities

Diseases

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 NCT01631266 on ClinicalTrials.gov