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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-022302-41 | EudraCT Number |
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Recruitment rythm not sufficent to reach the simple size needed.
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| Name | Class |
|---|---|
| Spanish Network for Research in Infectious Diseases | OTHER |
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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
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
To demonstrate that the efficacy of levofloxacin is not limited by adverse effects, paying particular attention to hepatotoxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| levofloxacin | Experimental | Levofloxacin 500 mg daily for 9 months starting on the waiting list for liver transplant |
|
| Isoniazid | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levofloxacin | Drug | Levofloxacin |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 18 months of follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Number of deaths of any cause | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Drug tolerance will be evaluated by a clinical study interview and periodic analytical determinations which will include levels of transaminases (ALT and AST), alkaline phosphatase and gamma-GT, bilirubin, according to the study visit schedule. All symptoms and laboratory results will be evaluated for severity according to the grading (severity) scale of the National Cancer Institute Common Toxicity Criteria Version 3.0, NCI-CTC-AE v 3.0. |
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:
The patient must give their written informed consent.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julián de la Torre Cisneros, MD | Hospital Universitario Reina Sofía, Córdoba, Spain | Principal Investigator |
| José M. Aguado, MD, PhD | Hospital Universitario 12 de Octubre, Madrid | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complejo Hospitalario Universitario | A Coruña | Spain | ||||
| Complejo Hospitalario de Albacete |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19445585 | Background | Torre-Cisneros J, Doblas A, Aguado JM, San Juan R, Blanes M, Montejo M, Cervera C, Len O, Carratala J, Cisneros JM, Bou G, Munoz P, Ramos A, Gurgui M, Borrell N, Fortun 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. | |
| 9158022 |
| Label | URL |
|---|---|
| official web site for the Spanish Infectious Disease Network | View source |
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| Isoniazid | Drug | 300 mg/day for 9 months beginning after transplantation, when the "liver function is stable" and not before 3 months nor after 6 months. |
|
|
| During all the 18 months of follow-up |
| Retransplantation | A new liver transplantation during the follow-up | 18 months |
| Graft dysfunction | Development of advanced graft fibrosis stages 3 and 4 | 18 months |
| Transplant rejection | The occurrence of acute rejection or chronic rejection as per conventional definitions during the follow-up. | 18 months |
| 18 months |
| 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 |
| Hospital Ramón y Cajal | Madrid | Spain |
| Hospital Universitario Puerta de Hierro | Madrid | Spain |
| Hospital Universitario Carlos Haya | Málaga | Spain |
| Hospital Virgen de la Arrixaca | Murcia | 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 |
| Background |
| Aguado JM, Herrero JA, Gavalda J, Torre-Cisneros J, Blanes M, Rufi G, Moreno A, Gurgui 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. doi: 10.1097/00007890-199705150-00015. |
| ID | Term |
|---|---|
| D055985 | Latent Tuberculosis |
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D000085343 | Latent Infection |
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| ID | Term |
|---|---|
| D064704 | Levofloxacin |
| D007538 | Isoniazid |
| ID | Term |
|---|---|
| D015242 | Ofloxacin |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006834 | Hydrazines |
| D009930 | Organic Chemicals |
| D007539 | Isonicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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