MedTrace Logo

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

NCT01761201 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2014-08-06

No results posted yet for this study

Summary

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.

Conditions

  • Latent Tuberculosis Infection
  • Infection in Solid Organ Transplant Recipients

Interventions

DRUG

Levofloxacin

Levofloxacin

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.

Sponsors & Collaborators

  • Spanish Network for Research in Infectious Diseases

    collaborator OTHER

  • Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

    lead OTHER

Principal Investigators

  • Julián de la Torre Cisneros, MD · Hospital Universitario Reina Sofía, Córdoba, Spain

  • José M. Aguado, MD, PhD · Hospital Universitario 12 de Octubre, Madrid

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01761201 on ClinicalTrials.gov