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.

Study Overview

• Status: Terminated
• Conditions: Tuberculosis
• Intervention / Treatment: Drug: I ( isoniazid), II (isoniazid + rifampin )

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.

• Study Type: Interventional
• Enrollment: 228
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Cuenca, Spain, 16002
    • Maria Paloma Geijo Martinez. Hospital Virgen de la Luz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 89 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
to compare the compliance
to compare the side effects

Secondary Outcome Measures

Outcome Measure
Development of tuberculosis

Collaborators and Investigators

• Sponsor: Hospital Virgen de la Luz
• Investigators: Principal Investigator: Maria Paloma Geijo Martinez, MD, Unidad MI-Infecciosas. Hospital Virgen de la Luz. Cuenca 16002 Spain

Publications and helpful links

General 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. doi: 10.1157/13102264. Spanish.

Helpful Links

• Page of infectious diseases of the region with studies on TB

Study record dates

Study Major Dates

• Study Start: March 1, 1996
• Study Completion: February 1, 2006

Study Registration Dates

• First Submitted: November 7, 2006
• First Submitted That Met QC Criteria: November 8, 2006
• First Posted (Estimate): November 9, 2006

Study Record Updates

• Last Update Posted (Estimate): December 31, 2008
• Last Update Submitted That Met QC Criteria: December 30, 2008
• Last Verified: November 1, 2006

More Information

Terms related to this study

• Keywords: Latent tuberculosis infection.; Isoniazid.; Rifampin.; Clinical trial.; treatment of latent tuberculosis infection
• Additional Relevant MeSH Terms: Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Latent Infection; Infections; Tuberculosis; Latent Tuberculosis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antimetabolites; Hypolipidemic Agents; Lipid Regulating Agents; Anti-Bacterial Agents; Leprostatic Agents; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; Antitubercular Agents; Antibiotics, Antitubercular; Cytochrome P-450 CYP2B6 Inducers; Cytochrome P-450 CYP2C8 Inducers; Cytochrome P-450 CYP2C19 Inducers; Cytochrome P-450 CYP2C9 Inducers; Fatty Acid Synthesis Inhibitors; Rifampin; Isoniazid
• Other Study ID Numbers: TBQXCU2; TBQXPNCU1