Short-Course Isoniazid and Rifampin Compared With Isoniazid for Latent Tuberculosis Infection
2 other identifiers
interventional
228
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 1996
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 1996
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 7, 2006
CompletedFirst Posted
Study publicly available on registry
November 9, 2006
CompletedDecember 31, 2008
November 1, 2006
November 7, 2006
December 30, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
to compare the compliance
to compare the side effects
Secondary Outcomes (1)
Development of tuberculosis
Interventions
Eligibility Criteria
You may qualify if:
- patients with positive TST and the suitable criteria for treatment, in accordance with the guidelines of the CDC:
You may not qualify if:
- HIV infection.
- Hepatopathy
- Previous treatment of of latent tuberculosis infection.
- Allergy to drugs.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maria Paloma Geijo Martinez. Hospital Virgen de la Luz
Cuenca, Cuenca, 16002, Spain
Related Publications (1)
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.
PMID: 17504682DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maria Paloma Geijo Martinez, MD
Unidad MI-Infecciosas. Hospital Virgen de la Luz. Cuenca 16002 Spain
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 7, 2006
First Posted
November 9, 2006
Study Start
March 1, 1996
Study Completion
February 1, 2006
Last Updated
December 31, 2008
Record last verified: 2006-11