Multi-drug Resistant Tuberculosis Clinical Trial
Official title:
Pharmacokinetics of Levofloxacin in MDR-TB Patients
The emergence and spread of multi-drug resistant and extensively-drug resistant strains of
Mycobacterium tuberculosis (MDR/XDR-TB) have posed a great threat to global TB control and
elimination, limiting treatment success rate at worrisome 50% for MDR-TB. Among various
factors contributing to the development of drug resistance, low drug exposure is well
recognized. To overcome this, either new drugs have to be developed or the dose of currently
used therapy be optimized, or both. Fluoroquinolones (levofloxacin and moxifloxacin) and
aminoglycosides are important drugs in the MDR-TB treatment regimen. Development of acquired
drug resistance to these drugs could complicate and narrow down the available options, and
further exacerbate to pre-XDR and XDR-TB.
Objective:
The main objective of this prospective clinical study is to understand the pharmacokinetics
of levofloxacin in MDR-TB patients, receiving standard dosage (750-1250mg) based on the body
weight and correlate drug exposure, with treatment outcomes.
Study design:
A prospective pharmacokinetic study
Study population: 20 MDR-TB patients
Intervention: Patients receive once daily oral dosing of levofloxacin (750-1250mg) based on
the body weight, under MDR-TB treatment regimen of Nepal.
Main study parameters/end points:
The pharmacokinetic parameters(Vd, CL, AUC etc.) of levofloxacin are the primary end points
of the study. The Cmax/MIC and AUC0-24h/MIC ratios are the best predictive parameters for
efficacy of levofloxacin treatment and will be estimated. Pharmacokinetics will be evaluated
in plasma and in oral fluid
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03057756 -
Treatment of Tuberculosis Multidrug Resistance Treatment of Tuberculosis Multidrug Resistance
|
||
| Completed |
NCT04207112 -
Economic Evaluation of New MDR TB Regimens
|
Phase 2/Phase 3 | |
| Completed |
NCT03470233 -
Post Marketing Registry to Assess Usage, Safety and Effectiveness of Deltyba Tablets in Korean Patients With MDR-TB
|
||
| Completed |
NCT03830671 -
The Effect of 18-month Regimen Containing 6 Anti-tuberculosis Drugs for Patients With MDR-TB
|
Phase 4 | |
| Withdrawn |
NCT01600963 -
A Study to Evaluate the Efficacy and Safety of TMC207 in Patients With Pulmonary Infection With Multi-drug Resistant Mycobacterium Tuberculosis
|
Phase 3 | |
| Recruiting |
NCT03575299 -
Clinical Study on Adoptive Treatment of MDR-TB With Allogeneic γδT Cells
|
Phase 1 | |
| Recruiting |
NCT03827811 -
Pharmacometrics to Advance Novel Regimens for Drug-resistant Tuberculosis-PandrTB Tuberculosis
|
||
| Completed |
NCT04342598 -
Case Control Study of Vitamin D Status and Adult Multidrug-resistant Pulmonary Tuberculosis in Maharashtra, India
|
||
| Completed |
NCT04309656 -
A Study in Two Panels of Healthy Adult Participants to Assess Single-Dose Immediate-Release and Single-Dose Dispersible Formulations of Pretomanid
|
Phase 1 | |
| Completed |
NCT03822156 -
Clinical Analysis of the Patients With Cavitary Pulmonary TB and Endobronchial TB in the PPM-UUH Cohort
|
||
| Completed |
NCT00425113 -
Metronidazole for Pulmonary Tuberculosis (South Korea)
|
Phase 2 | |
| Active, not recruiting |
NCT04081077 -
PRACTECAL-PKPD Sub Study
|
Phase 2/Phase 3 | |
| Recruiting |
NCT04397536 -
New Genomic Techniques and Management of Multidrug-resistant Tuberculosis
|
||
| Completed |
NCT00664313 -
TBTC Study 30: Safety and Tolerability of Low Dose Linezolid in MDR TB
|
Phase 1/Phase 2 | |
| Completed |
NCT00691392 -
Linezolid Pharmacokinetics (PK) in Multi-Drug Resistant (MDR)/Extensively-Drug Resistant (XDR) Tuberculosis (TB)
|
Phase 1/Phase 2 |