None listed
Conditions
Interventions
GROUP A Type of group
Each member of this group, composed of patients with TB diagnosis who have been in treatment for less than 96 hours, will receive the application 5 patches with MPT64 for TB diagnosis 3 patches on one forearm and 2 on the other with the following content:
1. 150 micrograms of MPT64.
2. 300 micrograms of MPT64.
3. 600 micrograms of MPT64.
4. MPT64 placebo solution.
5. 150 micrograms of MPT64 (from the previous test batch).
These patches will be removed after 48 to 96 hours.
G
Each member of this group, comprised of TB diagnosis patients who have been in treatment for more than 30 days, will receive the application 5 patches with MPT64 for TB diagnosis 3 patches on one forearm and 2 on the other with the following content :
1. 150 micrograms of MPT64.
2. 300 micrograms of MPT64.
3. 600 micrograms of MPT64.
4. MPT64 placebo solution.
5. 150 micrograms of MPT64 (from the previous test batch).
These patches will be removed after 48 to 96 hours.
Sponsors
SEQUELLA INC.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Be between 18 and 65 years of age. 2. Voluntarily give written informed consent before any procedure related to the study that is not part of routine medical care. Patients included in Group A must meet the following additional inclusion criteria: 3. Have a positive AFB smear result, for a sample taken no later than the two weeks prior to day zero (0) of the study. Patients included in group C must meet the following additional inclusion criteria: 4. Have a positive AFB smear result, for a sample generated within the last 120 days. 5. Have been in treatment for TB for a period of between 30 and 90 days.
Exclusion criteria
Exclusion criteria: 1. Have participated in any clinical trial, in which a research product has been administered, within 60 days prior to the start of the study. 2. Have participated in a clinical trial involving the MPT64 patch test, at whatever time it occurred. 3. Have a positive or inconclusive result of detecting HIV in the blood. 4. Being immunosuppressed for any reason. 5. Suffer a serious physical or psychiatric illness that could interfere with the completion of the procedures of this protocol. Those who meet any of the following additional exclusion criteria will not be included in Group A: 6. Have been in the treatment against TB for more than 96 hours. Those who meet any of the following additional exclusion criteria will not be included in Group B: 7. Have an X-ray that suggests the presence of active TB. 8. Those who report having been in contact with a person with active TB within the past two years. 9. Have been interned in the last two years. 10. Present signs or symptoms that suggest active TB. 11. Having had active TB in the past.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The positivity and negativity of the MPT64 patch will be evaluated with respect to the seropositivity for TB in the AFB smear. Various parameters that define the response will be evaluated: vesicle formation, number of existing vesicles. Measure:Sensitivity and specificity of the patch test. Timepoints:48-96 hours after the application of the patch. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation of Adverse Reactions (AR): Defined as any harmful medical case in a person to whom a pharmaceutical product is supplied, which does not necessarily have a causal relationship with the treatment and gradation according to its veracity. Complete physical examination and evaluation of vital signs. Laboratory tests: According to clinical criteria. Measure:Safety: Incidence of adverse reactions, changes in vital signs and physical examination, changes in laboratory tests. Timepoints:Days 3 and 6. | — |
Countries
Peru
Outcome results
None listed