NCT01642888

A Trial in Subjects Suspected to Have Tuberculosis, Comparing the Diagnostic Performance of C-Tb to QuantiFERON®, in Combination With a Safety Assessment of C-Tb Versus Tuberculin PPD RT23 SSI

A Phase III Trial in Subjects Suspected to Have Tuberculosis, Comparing the Diagnostic Performance of C-Tb to QuantiFERON®-TB Gold In-Tube, in Combination With a Double Blind Randomized Split Body Safety Assessment of C-Tb Versus 2 T.U. Tuberculin PPD RT23 SSI (PPD)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,190 (actual)
• Sponsor: Statens Serum Institut · Academic / Other
• Sex: All
• Age: 28 Days – 65 Years
• Healthy volunteers: Accepted

Summary

Tuberculosis (TB) continues to be one of the most serious bacterial infections worldwide and therefore new improved diagnostic tests are needed to help doctors in diagnosing TB. The new skin test is 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 investigators hope that this new C-Tb skin test will be more precise (specific) than the PPD test, as the PPD test e.g. may show a reaction if the person tested is BCG vaccinated. The aim of this trial is to test the C-Tb skin test in volunteers suspected of having TB disease. With focus on age, HIV status and CD4 count the following analyses are done (in an overall perspective): * 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.

Detailed description

The TESEC-05 trial is an open comparison of the diagnostics performance of C-Tb compared to the QuantiFERON®-TB Gold In-Tube, in combination with a double-blind randomized split-body safety assessment of C-Tb versus to 2 T.U. Tuberculin PPD RT23 SSI. The trial is a multi-centre Phase III clinical trial designed specifically to address C-Tb in relation to the paediatric population and to HIV infection. The intention is to evaluate how the C-Tb test performs in the paediatric population with respect to safety, and to ensure that SSI will be able to extrapolate data obtained in an adult population to the paediatric population. Furthermore, the intention is both to evaluate the diagnostic performance and safety of C-Tb in HIV infected individuals and to evaluate whether SSI will be able to extrapolate data obtained in a non-HIV population to a HIV population. The trial population will consist of paediatric participants with suspected TB infection and adult participants suspected to have TB disease. Furthermore a control group of 100 children between 5 - 11 years of age with no symptoms or known exposure will be recruited from an area with a "low" prevalence of TB (an area with an incidence rate \< 299/100,000 per year, the average rate of TB in South Africa in 2005 was 645/100,000 per year. The trial will be conducted in South Africa where the prevalence of HIV infection is high and MTb infections are endemic. BCG vaccination at birth has been common practice since 1961 in South Africa. Thus most of the participants are presumed BCG vaccinated.

Conditions

• Tuberculosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2012-09-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2012-07-17
• Last updated: 2016-04-14

Locations

9 sites across 1 country: South Africa