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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
68
Levofloxacin
300 mg/day for 9 months beginning after transplantation, when the "liver function is stable" and not before 3 months nor after 6 months.
Complejo Hospitalario Universitario
A Coruña, Spain
Complejo Hospitalario de Albacete
Albacete, Spain
Hospital Infanta Cristina,
Badajoz, Spain
Hospital Clinic
Barcelona, Spain
Hospital Vall d'Hebron
Barcelona, Spain
Hospital de Cruces
Bilbao, Spain
Hospital Reina Sofía
Córdoba, Spain
Hospital universitario Virgen de las Nieves
Granada, Spain
Hospital 12 de Octubre
Madrid, Spain
Hospital Gregorio Marañón
Madrid, Spain
...and 8 more locations
Difference in incidence of tuberculosis disease
A patient will be considered as having tuberculosis when Mycobacterium tuberculosis is isolated by culture or M. Tuberculosis DNA is isolated from a representative clinical sample, organ fluid or tissue by polymerase chain reaction. Also cases of histopathologically confirmed tuberculosis (caseating granulomas with/without demonstration of acid-alcohol resistant bacillus \[BAAR\]) and clinically compatible presentation will be accepted. Tuberculosis will be classified as pulmonary (pulmonary parenchymal involvement), extrapulmonary (involvement of different organs to the lung) or disseminated (involvement of at least two non-contiguous organs). Cases where tuberculosis is diagnosed on the basis of clinical and/or radiology suspicion and for whom the corresponding physician has prescribed a specific treatment will not be accepted.
Time frame: 18 months of follow-up
Mortality
Number of deaths of any cause
Time frame: 18 months
Toxicity
Occurrence of grade 3 or 4 toxicities according to the grading (severity) scale of the National Cancer Institute Common Toxicity Criteria Version 4.0, NCI-CTC-AE v 4.0.
Time frame: During all the 18 months of follow-up
Retransplantation
A new liver transplantation during the follow-up
Time frame: 18 months
Graft dysfunction
Development of advanced graft fibrosis stages 3 and 4
Time frame: 18 months
Transplant rejection
The occurrence of acute rejection or chronic rejection as per conventional definitions during the follow-up.
Time frame: 18 months
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