A Phase 3 interventional study of Levofloxacin and Isoniazid in Latent Tuberculosis Infection and Infection in Solid Organ Transplant Recipients, sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla. Terminated at 18 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-08-06.
Sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Phase 3, Interventional, and Treatment
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
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 68 is below the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Fundación Pública Andaluza para la gestión de la Investigación en Sevilla is the lead sponsor of 119 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
Levofloxacin 500 mg daily for 9 months starting on the waiting list for liver transplant
Drug: Levofloxacin
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
Drug: Isoniazid
Levofloxacin
Also known as: Generic name: Levofloxacin, ATC Code: J01MA., Pharmaceutical form: Levofloxacin 500 mg film-coated tablets
300 mg/day for 9 months beginning after transplantation, when the "liver function is stable" and not before 3 months nor after 6 months.
Also known as: Generic name: Isoniazid., ATC Code: J04AC, Pharmaceutical form: tablets.
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.
Time frame: 18 months of follow-up
Mortality
Number of deaths of any cause
Time frame: 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.
Time frame: During all the 18 months of follow-up
Retransplantation
A new liver transplantation during the follow-up
Time frame: 18 months
Graft dysfunction
Development of advanced graft fibrosis stages 3 and 4
Time frame: 18 months
Transplant rejection
The occurrence of acute rejection or chronic rejection as per conventional definitions during the follow-up.
Time frame: 18 months
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.
Time frame: 18 months
This study is terminated, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
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Fundación Pública Andaluza para la gestión de la Investigación en Sevilla