Short-Course Isoniazid and Rifampin Compared With Isoniazid for Latent Tuberculosis Infection
Primary Purpose
Tuberculosis
Status
Terminated
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
I ( isoniazid), II (isoniazid + rifampin )
Sponsored by
About this trial
This is an interventional treatment trial for Tuberculosis focused on measuring Latent tuberculosis infection., Isoniazid., Rifampin., Clinical trial., treatment of latent tuberculosis infection
Eligibility Criteria
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.
Sites / Locations
- Maria Paloma Geijo Martinez. Hospital Virgen de la Luz
Outcomes
Primary Outcome Measures
to compare the compliance
to compare the side effects
Secondary Outcome Measures
Development of tuberculosis
Full Information
NCT ID
NCT00397709
First Posted
November 7, 2006
Last Updated
December 30, 2008
Sponsor
Hospital Virgen de la Luz
1. Study Identification
Unique Protocol Identification Number
NCT00397709
Brief Title
Short-Course Isoniazid and Rifampin Compared With Isoniazid for Latent Tuberculosis Infection
Official Title
Short-Course Isoniazid and Rifampin Compared With Isoniazid for Latent Tuberculosis Infection: A Randomized Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2006
Overall Recruitment Status
Terminated
Study Start Date
March 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital Virgen de la Luz
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis
Keywords
Latent tuberculosis infection., Isoniazid., Rifampin., Clinical trial., treatment of latent tuberculosis infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
228 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
I ( isoniazid), II (isoniazid + rifampin )
Primary Outcome Measure Information:
Title
to compare the compliance
Title
to compare the side effects
Secondary Outcome Measure Information:
Title
Development of tuberculosis
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Paloma Geijo Martinez, MD
Organizational Affiliation
Unidad MI-Infecciosas. Hospital Virgen de la Luz. Cuenca 16002 Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maria Paloma Geijo Martinez. Hospital Virgen de la Luz
City
Cuenca
ZIP/Postal Code
16002
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
17504682
Citation
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. doi: 10.1157/13102264. Spanish.
Results Reference
derived
Links:
URL
http://sescam.jccm.es/web1/home.do
Description
Page of infectious diseases of the region with studies on TB
Learn more about this trial
Short-Course Isoniazid and Rifampin Compared With Isoniazid for Latent Tuberculosis Infection
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