A Phase II Dose-Finding Study of the Patch Test for Diagnosis of Active Tuberculosis

Not Applicable

• Conditions: -A159 Respiratory tuberculosis unspecified, confirmed bacteriologically and histologically; Respiratory tuberculosis unspecified, confirmed bacteriologically and histologically; A159

• Registration Number: PER-054-06
• Lead Sponsor: SEQUELLA INC.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-09-27
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified