Last reviewed · How we verify
"A Prospective, Randomized, Comparative Clinical Trial of the Efficacy and Safety of Levofloxacin Versus Isoniazid in the Treatment of Latent Tuberculosis Infection in Liver Transplant Patients". (FLISH-ILT)
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.
Details
| Lead sponsor | Fundación Pública Andaluza para la gestión de la Investigación en Sevilla |
|---|---|
| Phase | Phase 3 |
| Status | TERMINATED |
| Enrolment | 68 |
| Start date | 2012-01 |
| Completion | 2014-02 |
Conditions
- Latent Tuberculosis Infection
- Infection in Solid Organ Transplant Recipients
Interventions
- Levofloxacin
- Isoniazid
Primary outcomes
- Difference in incidence of tuberculosis disease — 18 months of follow-up
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.
Countries
Spain