None listed
Conditions
Interventions
99 symptomatic subjects suspected of having tuberculosis (TB) of the lung were enrolled by placing the MPT64 patch with the Tween-80 detergent during the first visit.
Group name:Group B Type of group
75 healthy controls without signs or symptoms of tuberculosis. They receive the MPT64 patch at the time of the recruitment, at the next visit PPD is applied and three months later their tbc status is determined
Sponsors
SEQUELLA INC.,
Eligibility
Inclusion criteria
Inclusion criteria: • 18 -65 years of age inclusive • The individual will receive information related to the purpose of the study, an explanation of all the procedures involved, and the possible risks and benefits • The individual must certify their voluntary participation in the study by signing an informed consent form (appendix 1). Only groups A and C: the following criteria must be met at the initial visit for an individual to participate in the study as part of the symptomatic population group (groups A and C): • The individual should be referred to the place of clinical study for medical evaluation of a respiratory infection, or he should present himself with symptoms suggestive of Tuberculosis. • The individual must show signs and symptoms of pulmonary tuberculosis (example: persistent cough, hemoptysis, loss of appetite, weight loss, night sweats or fever), with this the doctor will recognize him as a patient suspected of Tuberculosis. Group B only: the following criteria must be met at the initial visit for an individual to participate in the study as part of the healthy population group (group B): • Tuberculosis excluded by negative smear, if a sputum sample could be collected; if this is not possible, then Tuberculosis should be excluded through a negative clinical examination, including a negative chest radiograph: • The individual must be free of active TB disease in the last two years, and any tuberculous treatment must have been completed more than one year before the uptake in the study. • The individual should not have regular contact with a person who has active TB. • A negative test result for HIV must be obtained within a week prior to enrollment in the study. • The study doctor or nurse believes that the participant does not have active TB.
Exclusion criteria
Exclusion criteria: • Individuals who can not (for example due to mental incapacity) or do not want to give informed consent for any reason. • Individuals who refuse counseling and an HIV test. • Individuals who have participated in a clinical trial in which a research product was administered in the last six months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Group A (individual search for lung conditions and those with TB symptoms) will be used to measure sensitivity. Therefore, Group B (healthy controls) will be used to examine specificity. Measure:Sensitivity and specificity of the MPT64 patch test Timepoints:During treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:They will include 95% confidence intervals for sensitivity, specificity Measure:Sensitivity and specificity of the MPT64 patch test in the diagnosis of pulmonary tuberculosis for different cases of TB Timepoints:During treatment ; Outcome name:Characterize the histological response at the patch site in those who react positively using skin biopsy samples. Measure:Histological response Timepoints:After treatment | — |
Outcome results
None listed