Tuberculosis Clinical Trial
Official title:
A Phase IIb Sensitivity Trial of the Diagnostic Agent C-Tb, When Given Intradermally by the Mantoux Technique to Adult Patients Recently Diagnosed With Active TB
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.
The new skin test is named C-Tb. Like the current Tuberculin Skin Test (TST), the C-Tb test
is injected just under the skin and will when positive show a 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 adults diagnosed with TB to determine
if a TB infected individual has a truly positive test result (this is called to find the
sensitivity of the skin test).
The trial is designed to investigate the sensitivity of C-Tb using various sizes of cut-off
of induration in a double blind randomised, split-body study comparing 0.1 µg/0.1 mL C-Tb
with the reference agent 2 T.U. Tuberculin PPD RT23 SSI. (Each volunteer receives the C-Tb
agent in one arm and 2 T.U. Tuberculin PPD RT 23 SSI in the other arm). Two groups of adult
patients recently diagnosed with active TB will be investigated; patients in the main group
will NOT have a co-infection with HIV and patients in the second group will have a
co-infection with HIV.
The C-Tb and 2 TU Tuberculin PPD RT 23 SSI agents are given concomitantly to each volunteer
in the RIGHT AND LEFT forearms according to a double blind randomisation scheme.
The primary objectives are to assess the sensitivity of the C-Tb test as a function of the
cut-off value (i.e., the smallest size of induration measured in mm resulting in a positive
outcome of the C-Tb test) when the test is administered intradermally by the Mantoux
technique to HIV negative adult patients recently diagnosed with active TB and to assess the
sensitivity of the C-Tb test as a function of the cut-off value (i.e., the smallest size of
induration measured in mm resulting in a positive outcome of the C-Tb test) when the test is
administered intradermally by the Mantoux technique to HIV positive adult patients recently
diagnosed with active TB The sensitivity is defined as the relative frequency of patients
with an induration response ≥ cut-off in TB patients.
Similarly the specificity of the C-Tb test is defined as the relative frequency of subjects
in a healthy population (i.e., no exposure to M. tuberculosis) who have an induration
response < cut-off after a C-Tb test.
An optimal cut-off point of being infected will be determined by combing the results from
the present sensitivity study with those from a parallel specificity study in (BCG
vaccinated) individuals with no previous exposure to M. tuberculosis.
The secondary objectives of the trial is to compare the induration response of C-Tb with the
induration response of 2 T.U. Tuberculin PPD RT 23 SSI, to compare the induration response
of C-Tb with the in-vitro IFN-γ response measured at screening using the QuantiFERON®-TB
Gold In Tube assay, to correlate the induration response to the initial CD4+ counts in HIV
positive patients and to record all adverse events (local and systemic) occurring within 28
days after application of the agents
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic
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