Latent Tuberculosis Infection Clinical Trial
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".
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
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04094012 -
Risk of SDRs Under 3HP and 1HP Regimen for LTBI
|
Phase 3 | |
| Completed |
NCT01582711 -
Study 33: Adherence to Latent Tuberculosis Infection Treatment 3HP SAT Versus 3HP DOT
|
Phase 3 | |
| Recruiting |
NCT06033807 -
Active Screening of Latent Tuberculosis Infection in School Contacts of Active Tuberculosis Patients
|
||
| Completed |
NCT01622140 -
Prospective Comparison of the Tuberculin Skin Test and Interferon-Gamma Release Assays in Diagnosing Infection With Mycobacterium Tuberculosis and in Predicting Progression to Tuberculosis
|
||
| Completed |
NCT00557765 -
Use of a Gamma-IFN Assay in Contact Tracing for Tuberculosis in a Low-Incidence, High Immigration Area
|
N/A | |
| Completed |
NCT00463086 -
Isoniazid Plus Antiretroviral Therapy to Prevent Tuberculosis in HIV-infected Persons
|
N/A | |
| Active, not recruiting |
NCT01398618 -
Comparing Two Preventive Regimens for Latent Tuberculosis Infection (LTBI)
|
Phase 3 | |
| Recruiting |
NCT00905970 -
Demonstration of the Dynamic Hypothesis of Latent Tuberculosis Infection
|
N/A | |
| Recruiting |
NCT00449345 -
Screening for Latent Tuberculosis in Healthcare Workers With Quantiferon-Gold Assay: A Cost-Effectiveness Analysis
|
N/A | |
| Completed |
NCT02641106 -
VDOT for Monitoring Adherence to LTBI Treatment
|
N/A | |
| Completed |
NCT00804713 -
Screening for Latent Tuberculosis Infection (LTBI) in US Army Recruits
|
N/A | |
| Completed |
NCT01136161 -
Clinical Trial to Investigate the Safety, Tolerability, and Immunogenicity of the Novel Antituberculous Vaccine RUTI® Following One Month of Isoniazid Treatment in Subjects With Latent Tuberculosis Infection
|
Phase 2 | |
| Recruiting |
NCT03312647 -
Adverse Drug Reactions to Anti-TB Drugs in the Treatment of Latent Tuberculosis Infection
|
N/A | |
| Completed |
NCT02810678 -
Enhancing the Public Health Impact of Latent Tuberculosis (TB) Infection Diagnosis and Treatment
|
N/A | |
| Completed |
NCT01223534 -
QuantiFERON®-TB Gold In-Tube for the Diagnosis of Tuberculosis Infection in Contact Tracing Study.
|
Phase 4 | |
| Withdrawn |
NCT00558480 -
Vitamin A Supplementation for Modulation of Mycobacterium Tuberculosis Immune Responses in Latent Tuberculosis
|
N/A | |
| Recruiting |
NCT00692809 -
Impact of HIV Infection on Latent Tuberculosis (TB) Among Patients With HIV-TB Co-infection
|
N/A | |
| Completed |
NCT03702049 -
Nurse-Led Community Health Worker Adherence Model in 3HP Delivery Among Homeless Adults at Risk for TB Infection and HIV
|
N/A | |
| Completed |
NCT01608685 -
Interferon Gamma Release Assays (IGRA) Testing Versus Tuberculin Skin Test in Renal Transplant Recipients
|
N/A | |
| Completed |
NCT01007396 -
Diagnosis of Tuberculosis Infection in Health Care Workers Using Ex-vivo Interferon-gamma Assay
|
N/A |