Trials / Terminated
TerminatedNCT01761201
"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".
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 68 (actual)
- Sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
Primary Objective 1. 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 2. To demonstrate that the efficacy of levofloxacin is not limited by adverse effects, paying particular attention to hepatotoxicity.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Levofloxacin | Levofloxacin |
| 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. |
Timeline
- Start date
- 2012-01-01
- Primary completion
- 2014-02-01
- Completion
- 2014-02-01
- First posted
- 2013-01-04
- Last updated
- 2014-08-06
Locations
18 sites across 1 country: Spain
Source: ClinicalTrials.gov record NCT01761201. Inclusion in this directory is not an endorsement.