"Efficacy and Safety of Levofloxacin vs Isoniazid in Latent Tuberculosis Infection in Liver Transplant Patients". (FLISH-ILT)
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| ClinicalTrials.gov Identifier: NCT01761201 |
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Recruitment Status :
Terminated
(Recruitment rythm not sufficent to reach the simple size needed.)
First Posted : January 4, 2013
Last Update Posted : August 6, 2014
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Latent Tuberculosis Infection Infection in Solid Organ Transplant Recipients | Drug: Levofloxacin Drug: Isoniazid | Phase 3 |
Primary Objective
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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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 68 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 Start Date : | January 2012 |
| Actual Primary Completion Date : | February 2014 |
| Actual Study Completion Date : | February 2014 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: levofloxacin
Levofloxacin 500 mg daily for 9 months starting on the waiting list for liver transplant
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Drug: Levofloxacin
Levofloxacin
Other Names:
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Active Comparator: Isoniazid
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
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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.
Other Names:
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- Difference in incidence of tuberculosis disease [ Time Frame: 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.
- Mortality [ Time Frame: 18 months ]Number of deaths of any cause
- Toxicity [ Time Frame: During all the 18 months of follow-up ]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.
- Retransplantation [ Time Frame: 18 months ]A new liver transplantation during the follow-up
- Graft dysfunction [ Time Frame: 18 months ]Development of advanced graft fibrosis stages 3 and 4
- Transplant rejection [ Time Frame: 18 months ]The occurrence of acute rejection or chronic rejection as per conventional definitions during the follow-up.
- Safety [ Time Frame: 18 months ]
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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01761201
Show 18 study locations
| Principal Investigator: | Julián de la Torre Cisneros, MD | Hospital Universitario Reina Sofía, Córdoba, Spain | |
| Study Chair: | José M. Aguado, MD, PhD | Hospital Universitario 12 de Octubre, Madrid |
Publications:
| Responsible Party: | Fundación Pública Andaluza para la gestión de la Investigación en Sevilla |
| ClinicalTrials.gov Identifier: | NCT01761201 |
| Other Study ID Numbers: |
FLISH-ILT 2010-022302-41 ( EudraCT Number ) |
| First Posted: | January 4, 2013 Key Record Dates |
| Last Update Posted: | August 6, 2014 |
| Last Verified: | August 2014 |
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Prophylaxis Tuberculosis Transplant recipients Transplant waiting list |
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Infections Communicable Diseases Tuberculosis Latent Tuberculosis Disease Attributes Pathologic Processes Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Latent Infection Levofloxacin Ofloxacin Isoniazid |
Anti-Infective Agents, Urinary Anti-Infective Agents Anti-Bacterial Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Cytochrome P-450 CYP1A2 Inhibitors Cytochrome P-450 Enzyme Inhibitors Antitubercular Agents Fatty Acid Synthesis Inhibitors Hypolipidemic Agents Antimetabolites Lipid Regulating Agents |