"Efficacy and Safety of Levofloxacin vs Isoniazid in Latent Tuberculosis Infection in Liver Transplant Patients". (FLISH-ILT)

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Status and phase

Terminated

Phase 3

Conditions

Infection in Solid Organ Transplant Recipients

Latent Tuberculosis Infection

Treatments

Drug: Levofloxacin

Drug: Isoniazid

Study type

Interventional

Funder types

Other

Identifiers

NCT01761201

FLISH-ILT

2010-022302-41 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

Primary Objective

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

Enrollment

68 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).