Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00397709
Status:
TERMINATED
Last Update Posted:
2008-12-31
First Post:
2006-11-07
Brief Title:
Short-Course Isoniazid and Rifampin Compared With Isoniazid for Latent Tuberculosis Infection
Sponsor:
Hospital Virgen de la Luz
Organization:
Hospital Virgen de la Luz
Study Overview
Official Title:
Short-Course Isoniazid and Rifampin Compared With Isoniazid for Latent Tuberculosis Infection A Randomized Clinical Trial
Status:
TERMINATED
Status Verified Date:
2006-11
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 objective of the study was to compare the compliance and the side effects of a short course to treatment of latent tuberculosis infection during 3 monthsisoniazid plus rifampingroup I with the standard course for 6 monthsisoniazidgroup II Prospective comparative randomized and open trial of patients with positive TST and the suitable criteria for treatment in accordance with the guidelines of the CDC excluding HIV infection 105 patients were included In Conclusion a short course with isoniazid plus rifampin during 3 months shown better compliance with a lower percentage of abandonment that the course 6H Tolerance is similar in the two courses
Detailed Description:
Introduction The objective of the study was to compare the compliance and the side effects of a short course to treatment of latent tuberculosis infection during 3 months with the standard course for 6 months
Methods Prospective comparative randomized and open trial of patients with positive TST and the suitable criteria for treatment in accordance with the guidelines of the CDC excluding HIV infection the group I was assigned to isoniazid H at a dose of 300 mg per day for 6 months and the group II was assigned to isoniazid at a dose of 300 mg per day plus rifampin R 600 mg per day for 3 months The patients were followed for five years
Results 105 patients were included of which 9 refused the treatment 45 patients were included in the group I and 51 patients in the group II Both groups were comparable at base level The hepatotoxicity was 44 in the group 6H and 29 in the group 3HR p 007 The hepatotoxicity was severe in 67 in the group 6H and 58 in the group 3HR these obliged the suspension of treatment in 44 and 19 respectively p NS The proportion of patients who completed the study treatment was 756 of the patients in the group 6H and 902 in the group 3HR p 005 Only a case of tuberculosis was detected in the second month treatment with 6H
Conclusion In the treatment of latent tuberculosis infection a short course with isoniazid plus rifampin during 3 months shown better compliance with a lower percentage of abandonment that the course 6H Tolerance is similar in the two courses
Methods Prospective comparative randomized and open trial of patients with positive TST and the suitable criteria for treatment in accordance with the guidelines of the CDC excluding HIV infection the group I was assigned to isoniazid H at a dose of 300 mg per day for 6 months and the group II was assigned to isoniazid at a dose of 300 mg per day plus rifampin R 600 mg per day for 3 months The patients were followed for five years
Results 105 patients were included of which 9 refused the treatment 45 patients were included in the group I and 51 patients in the group II Both groups were comparable at base level The hepatotoxicity was 44 in the group 6H and 29 in the group 3HR p 007 The hepatotoxicity was severe in 67 in the group 6H and 58 in the group 3HR these obliged the suspension of treatment in 44 and 19 respectively p NS The proportion of patients who completed the study treatment was 756 of the patients in the group 6H and 902 in the group 3HR p 005 Only a case of tuberculosis was detected in the second month treatment with 6H
Conclusion In the treatment of latent tuberculosis infection a short course with isoniazid plus rifampin during 3 months shown better compliance with a lower percentage of abandonment that the course 6H Tolerance is similar in the two courses
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| TBQXPNCU1 | None | None | None |