Short-Course Isoniazid and Rifampin Compared With Isoniazid for Latent Tuberculosis Infection
|First Received Date ICMJE||November 7, 2006|
|Last Updated Date||December 30, 2008|
|Start Date ICMJE||March 1996|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00397709 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||Development of tuberculosis|
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Short-Course Isoniazid and Rifampin Compared With Isoniazid for Latent Tuberculosis Infection|
|Official Title ICMJE||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.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 4|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Intervention ICMJE||Drug: I ( isoniazid), II (isoniazid + rifampin )|
|Study Arm (s)||Not Provided|
|Publications *||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.
|Recruitment Status ICMJE||Terminated|
|Completion Date||February 2006|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||16 Years to 89 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Spain|
|NCT Number ICMJE||NCT00397709|
|Other Study ID Numbers ICMJE||TBQXCU2, TBQXPNCU1|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Hospital Virgen de la Luz|
|Collaborators ICMJE||Not Provided|
|Information Provided By||Hospital Virgen de la Luz|
|Verification Date||November 2006|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP