Active pulmonary tuberculosis. Infections and Infestations Tuberculosis
Conditions
Interventions
1. Diagnostic phase: application of a transdermal patch to each forearm, one containing placebo and the other MPT64 (study staff and patients blinded to allocation) with removal and reading of result
at months 9, 12, 15 and 18 all participants are investigated fully once more for TB (as above) and repeat patch testing is performed. In a subgroup of 30 consenting participants with positive reaction
Sponsors
Sequella Inc (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: TB suspects undergoing investigation at selected health centres for pulmonary TB within the National TB Control Programme of Peru.
Exclusion criteria
Exclusion criteria: 1. Age less than 18 or greater than 65 2. Inability or unwillingness to provide written informed consent 3. Participation in a clinical trial of another investigational product within the preceding 6 months 4. Refusal to undergo voluntary counselling and testing for human immunodeficiency virus (HIV) infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The objective is to assess the sensitivity and specificity of the MPT64 patch test in the diagnosis of pulmonary TB - the outcome of interest is therefore the concordance of patch test results with the results of the conventional gold-standard investigations performed concurrently. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess the above performance characteristics in patient subgroups including those with smear-positive disease and smear-negative disease 2. To determine the effect (if any) of age, HIV status, PPD response upon patch test performance 3. To determine the response over time of both initial reactors and non-reactors and TB and non-TB patients 4. To characterize the histological response in patch test reactors | — |
Countries
Peru
Outcome results
None listed