Trial | NCT01761201  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    68
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.
Study Started
Jan 31
2012
Primary Completion
Feb 28
2014
Study Completion
Feb 28
2014
Last Update
Aug 06
2014
Estimate

Drug Levofloxacin

Levofloxacin

  • Other names: Generic name: Levofloxacin, ATC Code: J01MA., Pharmaceutical form: Levofloxacin 500 mg film-coated tablets

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: ATC Code: J04AC, Generic name: Isoniazid., Pharmaceutical form: tablets.

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

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).
No Results Posted