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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00397709
First Posted: November 9, 2006
Last Update Posted: December 31, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hospital Virgen de la Luz
  Purpose
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.

Condition Intervention Phase
Tuberculosis Drug: I ( isoniazid), II (isoniazid + rifampin ) Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Short-Course Isoniazid and Rifampin Compared With Isoniazid for Latent Tuberculosis Infection: A Randomized Clinical Trial.

Resource links provided by NLM:


Further study details as provided by Hospital Virgen de la Luz:

Primary Outcome Measures:
  • to compare the compliance
  • to compare the side effects

Secondary Outcome Measures:
  • Development of tuberculosis

Estimated Enrollment: 228
Study Start Date: March 1996
Estimated Study Completion Date: February 2006
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 89 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00397709


Locations
Spain
Maria Paloma Geijo Martinez. Hospital Virgen de la Luz
Cuenca, Spain, 16002
Sponsors and Collaborators
Hospital Virgen de la Luz
Investigators
Principal Investigator: Maria Paloma Geijo Martinez, MD Unidad MI-Infecciosas. Hospital Virgen de la Luz. Cuenca 16002 Spain
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00397709     History of Changes
Other Study ID Numbers: TBQXCU2
TBQXPNCU1
First Submitted: November 7, 2006
First Posted: November 9, 2006
Last Update Posted: December 31, 2008
Last Verified: November 2006

Keywords provided by Hospital Virgen de la Luz:
Latent tuberculosis infection.
Isoniazid.
Rifampin.
Clinical trial.
treatment of latent tuberculosis infection

Additional relevant MeSH terms:
Infection
Tuberculosis
Latent Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Rifampin
Isoniazid
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents