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

This study has been terminated.
Sponsor:
Information provided by:
Hospital Virgen de la Luz
ClinicalTrials.gov Identifier:
NCT00397709
First received: November 7, 2006
Last updated: December 30, 2008
Last verified: November 2006

November 7, 2006
December 30, 2008
March 1996
Not Provided
  • to compare the compliance
  • to compare the side effects
Same as current
Complete list of historical versions of study NCT00397709 on ClinicalTrials.gov Archive Site
Development of tuberculosis
Same as current
Not Provided
Not Provided
 
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.

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Tuberculosis
Drug: I ( isoniazid), II (isoniazid + rifampin )
Not Provided
Geijo MP, Herranz CR, Vano D, Garcia AJ, Garcia M, Dimas JF. [Short-course isoniazid and rifampin compared with isoniazid for latent tuberculosis infection: a randomized clinical trial] Enferm Infecc Microbiol Clin. 2007 May;25(5):300-4. Spanish.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
228
February 2006
Not Provided

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.
Both
16 Years to 89 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00397709
TBQXCU2, TBQXPNCU1
Not Provided
Not Provided
Hospital Virgen de la Luz
Not Provided
Principal Investigator: Maria Paloma Geijo Martinez, MD Unidad MI-Infecciosas. Hospital Virgen de la Luz. Cuenca 16002 Spain
Hospital Virgen de la Luz
November 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP