Trial intelligence / Profile preview

Levofloxacin vs Isoniazid for Latent TB in Liver Transplant Candidates

NCT01761201Phase 3

Key facts

Status: Terminated
Start: Jan 2012
Primary completion: Feb 2014
Countries: 1
Sponsor: Fundación Pública Andaluza para la Gestión de la Investigación
Modality: Small Molecules

Drugs: levofloxacin
Conditions: Tuberculosis (TB)

Overview

Phase 3, randomised, open-label trial of levofloxacin in Tuberculosis (TB) (2 arms), sponsored by Fundación Pública Andaluza para la Gestión de la Investigación. Primary endpoint: Difference in incidence of tuberculosis disease at 18 months. Started Jan 2012; status: terminated.

Design

2 arms

Study design: RandomizedOpen-label

Levofloxacin
Levofloxacin 500 mg daily for 9 months starting on the waiting list
Isoniazid
Isoniazid 300 mg/day for 9 months beginning after transplantation

Who it enrols

Adult liver transplant candidates with latent tuberculosis infection (PPD > 5mm or positive IGRA) or history/radiological evidence of past untreated TB. Patients with active TB or recent quinolone use are excluded.

Endpoints

Primary

Difference in incidence of tuberculosis disease18 months

Secondary

Mortality18 months
Toxicity18 months
Retransplantation18 months
Graft dysfunction18 months
Transplant rejection18 months

Beyond the preview

Go deeper on NCT01761201.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT01761201.