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Short-Course Isoniazid and Rifampin Compared With Isoniazid for Latent Tuberculosis Infection

Short-Course Isoniazid and Rifampin Compared With Isoniazid for Latent Tuberculosis Infection: A Randomized Clinical Trial.

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00397709
Enrollment
228
Registered
2006-11-09
Start date
1996-03-31
Completion date
2006-02-28
Last updated
2008-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis

Keywords

Latent tuberculosis infection., Isoniazid., Rifampin., Clinical trial., treatment of latent tuberculosis infection

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 months(isoniazid plus rifampin)group I, with the standard course for 6 months(isoniazid)group 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 = 0,07). The hepatotoxicity was severe in 6.7% in the group 6H and 5.8% in the group 3HR; these obliged the suspension of treatment in 4.4% and 1.9%, respectively (p =NS). The proportion of patients who completed the study treatment was 75.6% of the patients in the group 6H, and 90.2% in the group 3HR (p = 0,05). 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.

Interventions

DRUGI ( isoniazid), II (isoniazid + rifampin )

Sponsors

Hospital Virgen de la Luz
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to 89 Years
Healthy volunteers
No

Inclusion criteria

* patients with positive TST and the suitable criteria for treatment, in accordance with the guidelines of the CDC:

Exclusion criteria

* HIV infection. * Hepatopathy * Previous treatment of of latent tuberculosis infection. * Allergy to drugs.

Design outcomes

Primary

MeasureTime frame
to compare the compliance
to compare the side effects

Secondary

MeasureTime frame
Development of tuberculosis

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026