Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00293228
Status:
COMPLETED
Last Update Posted:
2010-05-26
First Post:
2006-02-16
Brief Title:
Treatment of Latent Tuberculosis Infection With Isoniazid
Sponsor:
Instituto Nacional de Salud Publica Mexico
Organization:
Instituto Nacional de Salud Publica Mexico
Study Overview
Official Title:
Drugs for Treatment of Latent Tuberculosis Infection Objective 4 Identify Biomarkers for Clinical Trials of Drugs Active Against Latent TB
Status:
COMPLETED
Status Verified Date:
2010-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to study the effect that treatment of dormant tuberculosis infection has on the immunological system
We expect to observe an impact over the production of cytokines by peripheral white blood cells which may be useful to know if treatment has been effective
We expect to observe an impact over the production of cytokines by peripheral white blood cells which may be useful to know if treatment has been effective
Detailed Description:
As part of on-going studies conducted in the Orizaba Health Jurisdiction in southeastern Mexico household contacts of pulmonary TB patients who recently converted their tuberculin test and TSTve contacts from randomly selected control households with no history of TB within the last 2 years remote contacts will be enrolled We assume that these individuals are infected with Mycobacterium tuberculosis Additional confidence that all subjects enrolled are latently infected will come from ELISPOT analysis of the response to ESAT-6 and CFP-10 We propose to administer INH to 100 TSTve recent and 100 TSTve remote contacts for 6 months To control for spontaneous fluctuations of biomarker levels we propose to defer therapy by 3 months to half the subjects in each group Thus four groups will be defined
A Recently converted contacts receiving isoniazid 5mg per kg up to 300 mg daily for 6 months immediately after recruitment
B Recently converted contacts receiving isoniazid 5mg per kg up to 300 mg daily for 6 months three months after recruitment
C Remote contacts receiving isoniazid 5mg per kg up to 300 mg daily for 6 months immediately after recruitment
D Remote contacts receiving isoniazid 5mg per kg up to 300 mg daily for 6 months three months after recruitment
All contacts will undergo clinical evaluation at enrolment and review The development of active TB will trigger withdrawal and full treatment Fortnightly clinical review of group B during the deferred phase will be undertaken ELISPOT analysis will be performed on all subjects at 0 1 4 13 26 and 40 weeks in groups A and C and at 0 13 14 17 26 40 and 54 weeks in groups B and D A subset of 10 patients per group will be sampled for expression analysis at 0 4 26 and 40 weeks groups A and C and at 0 13 17 and 40 weeks in groups B and D 160 hybridizations in total
A Recently converted contacts receiving isoniazid 5mg per kg up to 300 mg daily for 6 months immediately after recruitment
B Recently converted contacts receiving isoniazid 5mg per kg up to 300 mg daily for 6 months three months after recruitment
C Remote contacts receiving isoniazid 5mg per kg up to 300 mg daily for 6 months immediately after recruitment
D Remote contacts receiving isoniazid 5mg per kg up to 300 mg daily for 6 months three months after recruitment
All contacts will undergo clinical evaluation at enrolment and review The development of active TB will trigger withdrawal and full treatment Fortnightly clinical review of group B during the deferred phase will be undertaken ELISPOT analysis will be performed on all subjects at 0 1 4 13 26 and 40 weeks in groups A and C and at 0 13 14 17 26 40 and 54 weeks in groups B and D A subset of 10 patients per group will be sampled for expression analysis at 0 4 26 and 40 weeks groups A and C and at 0 13 17 and 40 weeks in groups B and D 160 hybridizations in total
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None