"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 SofÃa, Córdoba, Spain José M. Aguado, MD, PhD, Study Chair, Affiliation: Hospital Universitario 12 de Octubre, Madrid
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.
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: MortalityToxicity Retransplantation 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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 SofÃa, 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
ClÃnica Universitaria de Navarra, Pamplona, Spain
Hospital Marqués de Valdecillas, Santander, Spain
Hospital Virgen del RocÃo, 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, Rufà G, Moreno A, Gurguà 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
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