Tuberculosis diagnostic tool MedDRA version: 14.1 Level: PT Classification code 10044755 Term: Tuberculosis System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: C-Tb
Product Code: C-Tb
Pharmaceutical Form: Solution for injection
INN or Proposed INN: rdESAT-6
Current Sponsor code: rdESAT-6
Concentration unit: µg/ml microgram(s)/millilitre
Concent
Sponsors
Statens Serum Institut
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Can comply with one of the following groups: a) Negative control group: Must have no history of exposure to a TB index case, and have no signs or symptoms of TB b) Positive control group: Confirmed TB disease within the last 3 years by sputum smear microscopy and/or Culture, Gene Xpert or PCR c) Close contact group: Must be in close contact with a pulmonary smear positive TB index case for more than 6 hours/day for at least five days d) Occasional contact group: Must be in contact with a pulmonary sputum smear positive TB index case between 6 hours/week and 6 hours/day 2.Is between 6 weeks - 65 years of age 3.Participant, parent or legal guardian has provided signed informed consent 4.Is willing and likely to comply with the trial procedures 5.Is prepared to grant authorized persons access to their medical record Are the trial subjects under 18? yes Number of subjects for this age range: 120 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 780 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Has been vaccinated with a live vaccine within 6 weeks prior to the day of inclusion (e.g. Mumps Measles Rubella (MMR), yellow fever, oral typhoid vaccines) 2.Has been tuberculin tested less than 12 months prior to the day of inclusion 3.Is pregnant, breastfeeding or intending to get pregnant within the trial period 4.Is a female of child bearing potential (12 years of age or older having had their first menstruation) not willing to use effective barrier (including spermicidal gel), hormonal or intrauterine contraceptive measures within the trial period 5.Has an active disease affecting the lymphoid organs except for HIV (e.g., Hodgkin?s disease, lymphoma, leukaemia, sarcoidosis) 6.Has a current skin condition which interferes with the reading of the C-Tb and Tuberculin PPD RT23 SSI e.g. tattoos, severe scarring, burns/sunburns, rash, eczema, psoriasis, or any other skin disease at or near the injection sites 7.Has a condition where blood drawings pose more than minimal risk for the participant, such as haemophilia, other coagulation disorders, or significantly impaired venous access 8.Current participation in another clinical trial with an investigational or non investigational drug or device, which in the opinion of investigator may interfere with this trial drug 9.Has participated in previous clinical trials investigating injections with ESAT-6 and/or CFP-10 antigens 10.Has a condition which in the opinion of the investigator is not suitable for participation in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -To compare the diagnostic performance of C-Tb to that of QuantiFERON®-TB Gold In-Tube -To compare the diagnostic performance of C-Tb to that of Tuberculin PPD RT23 SSI -To assess the safety of C-Tb;Secondary Objective: To asses the diagnostic outcome of C-Tb, QuantiFERON®-TB Gold In-Tube and Tuberculin PPD RT23 SSI between and within 4 groups defined by estimated risk of infection with M. tuberculosis (MTb).;Primary end point(s): -The specificity of C-Tb compared to that of QuantiFERON®-TB Gold In-Tube -The specificity of C-Tb compared to that of Tuberculin PPD RT23 SSI -The sensitivity of C-Tb compared to that of QuantiFERON®-TB Gold In-Tube -The sensitivity of C-Tb compared to that of Tuberculin PPD RT23 SSI;Timepoint(s) of evaluation of this end point: Reading of indurantion at 48-72 hours Quantiferon results: when available | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Response ratios for C-Tb, QuantiFERON®-TB Gold In-Tube and Tuberculin PPD RT23 SSI in 4 groups defined by estimated risk of infection with MTb. -The diameter of induration at the C-Tb injection site measured transversely to the long axis of the forearm at 2 to 3 days after intradermal administration of C-Tb -The diameter of induration at the Tuberculin PPD RT23 SSI injection site measured transversely to the long axis of the forearm at 2 to 3 days after intradermal administration of Tuberculin PPD RT23 SSI;Timepoint(s) of evaluation of this end point: Reading of indurantion at 48-72 hours Quantiferon results: when available | — |
Countries
Spain
Contacts
Public ContactClinical Trials Department
Statens Serum Institut
Outcome results
None listed