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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

228 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-03-31

Study Completion Date

2006-02-28

Brief Summary

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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

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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.

Conditions

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Tuberculosis

Keywords

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Latent tuberculosis infection. Isoniazid. Rifampin. Clinical trial. treatment of latent tuberculosis infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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I ( isoniazid), II (isoniazid + rifampin )

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

16 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Maria Paloma Geijo Martinez, MD

Role: PRINCIPAL_INVESTIGATOR

Unidad MI-Infecciosas. Hospital Virgen de la Luz. Cuenca 16002 Spain

Locations

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Maria Paloma Geijo Martinez. Hospital Virgen de la Luz

Cuenca, Cuenca, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED

PMID: 17504682 (View on PubMed)

Other Identifiers

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TBQXPNCU1

Identifier Type: -

Identifier Source: secondary_id

TBQXCU2