"Efficacy and Safety of Levofloxacin vs Isoniazid in Latent Tuberculosis Infection in Liver Transplant Patients".

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

PHASE3

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-02-28

Brief Summary

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A multicenter, prospective, non-inferiority, randomized and open clinical trial comparing levofloxacin with isoniazid in the treatment of latent tuberculosis infection in patients eligible for liver transplantation.

Patients over 18 years of age on the waiting list for liver transplantation.

Sample size: n=870 patients.

HYPOTHESIS

Levofloxacin treatment of latent tuberculosis infection, begun while on the waiting list for liver transplantation, is safer and not less effective than isoniazid treatment begun after transplantation when liver function is stable.

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Detailed Description

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Primary Objective

1. To demonstrate that the incidence of tuberculosis in patients with latent tuberculosis infection and treated with levofloxacin is not higher than that observed in patients treated with isoniazid.

Secondary Objective
2. To demonstrate that the efficacy of levofloxacin is not limited by adverse effects, paying particular attention to hepatotoxicity.

Conditions

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Latent Tuberculosis Infection Infection in Solid Organ Transplant Recipients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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levofloxacin

Levofloxacin 500 mg daily for 9 months starting on the waiting list for liver transplant

Group Type EXPERIMENTAL

Levofloxacin

Intervention Type DRUG

Levofloxacin

Isoniazid

Isoniazid 300 mg/day for 9 months beginning after transplantation, when the "liver function is stable" and not before 3 months nor after 6 months

Group Type ACTIVE_COMPARATOR

Isoniazid

Intervention Type DRUG

300 mg/day for 9 months beginning after transplantation, when the "liver function is stable" and not before 3 months nor after 6 months.

Interventions

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Levofloxacin

Intervention Type DRUG

Isoniazid

300 mg/day for 9 months beginning after transplantation, when the "liver function is stable" and not before 3 months nor after 6 months.

Intervention Type DRUG

Other Intervention Names

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Generic name: Levofloxacin ATC Code: J01MA. Pharmaceutical form: Levofloxacin 500 mg film-coated tablets Generic name: Isoniazid. ATC Code: J04AC Pharmaceutical form: tablets.

Eligibility Criteria

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Inclusion Criteria

Liver transplantation candidates with age ≥ 18 years, no clinical or radiological evidence of active tuberculosis and negative pregnancy test (if applicable)who must meet one or more of the following criteria:

* PPD skin test (initial or after a "booster effect") \>5 mm. Alternatively, the determination may be made by the interferon gamma (IFN-g) production in PPD-stimulated lymphocytes using the Quantiferon-TB or ELISPOT assays.
* Past history of tuberculosis not properly treated.
* Past history of contact with a patient with active TB.
* Chest x-ray consistent with past untreated TB (apical fibronodular lesions, calcified solitary nodule, calcified lymph nodes or pleural thickening).

The patient must give their written informed consent.

Exclusion Criteria

* Lack of consent to participate in the study.
* Intolerance or allergy to levofloxacin or to isoniazid.
* Documented contact with tuberculosis resistant to levofloxacin or to isoniazid.
* Treatment in the previous month with drugs with potential activity against Mycobacterium tuberculosis, (especially quinolones).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No