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

Tuberculosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00397709
• Other study ID #: TBQXCU2
• Secondary ID: TBQXPNCU1
• Status: Terminated
• Phase: Phase 4
• First received: November 7, 2006
• Last updated: December 30, 2008
• Start date: March 1996
• Est. completion date: February 2006

Study information

• Verified date: November 2006
• Source: Hospital Virgen de la Luz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 228
• Est. completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 89 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Latent Tuberculosis
• Tuberculosis

Intervention

Drug:
• I ( isoniazid), II (isoniazid + rifampin )

Locations

Country	Name	City	State
Spain	Maria Paloma Geijo Martinez. Hospital Virgen de la Luz	Cuenca

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Virgen de la Luz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to compare the compliance
Primary	to compare the side effects
Secondary	Development of tuberculosis

External Links

•   Page of infectious diseases of the region with studies on TB