DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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

Information source: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Latent Tuberculosis Infection; Infection in Solid Organ Transplant Recipients

Intervention: Levofloxacin (Drug); Isoniazid (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Official(s) and/or principal investigator(s):
Julián de la Torre Cisneros, MD, Principal Investigator, Affiliation: Hospital Universitario Reina Sofía, Córdoba, Spain
José M. Aguado, MD, PhD, Study Chair, Affiliation: Hospital Universitario 12 de Octubre, Madrid


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.

Clinical Details

Official title: "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".

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Difference in incidence of tuberculosis disease

Secondary outcome:




Graft dysfunction

Transplant rejection

Detailed description: 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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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).

Locations and Contacts

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

Complejo Hospitalario Universitario, Coruña, 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

Hospital Ramón y Cajal, Madrid, Spain

Hospital Universitario Puerta de Hierro, Madrid, Spain

Hospital Virgen de la Arrixaca, Murcia, Spain

Hospital Universitario Carlos Haya, Málaga, Spain

Clínica Universitaria de Navarra, Pamplona, Spain

Hospital Marqués de Valdecillas, Santander, Spain

Hospital Virgen del Rocío, Seville, Spain

Hospital Universitario La Fe, Valencia, Spain

Additional Information

Related publications:

Torre-Cisneros J, Doblas A, Aguado JM, San Juan R, Blanes M, Montejo M, Cervera C, Len O, Carratala J, Cisneros JM, Bou G, Muñoz P, Ramos A, Gurgui M, Borrell N, Fortún J, Moreno A, Gavalda J; Spanish Network for Research in Infectious Diseases. Tuberculosis after solid-organ transplant: incidence, risk factors, and clinical characteristics in the RESITRA (Spanish Network of Infection in Transplantation) cohort. Clin Infect Dis. 2009 Jun 15;48(12):1657-65. doi: 10.1086/599035.

Aguado JM, Herrero JA, Gavaldá J, Torre-Cisneros J, Blanes M, Rufí G, Moreno A, Gurguí M, Hayek M, Lumbreras C, Cantarell C. Clinical presentation and outcome of tuberculosis in kidney, liver, and heart transplant recipients in Spain. Spanish Transplantation Infection Study Group, GESITRA. Transplantation. 1997 May 15;63(9):1278-86. Review. Erratum in: Transplantation 1997 Sep 27;64(6):942.

Starting date: January 2012
Last updated: August 5, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017