Clinical Trials Logo

Clinical Trial Summary

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.


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

Clinical Trial Description


Study Design

Related Conditions & MeSH terms

  • Multi-drug Resistant Tuberculosis
  • Tuberculosis
  • Tuberculosis, Multidrug-Resistant

NCT number NCT03000517
Study type Observational
Source University Medical Center Groningen
Status Completed
Phase N/A
Start date May 4, 2016
Completion date January 24, 2018

See also
  Status Clinical Trial Phase
Recruiting NCT03057756 - Treatment of Tuberculosis Multidrug Resistance Treatment of Tuberculosis Multidrug Resistance
Recruiting NCT04207112 - Economic Evaluation of New MDR TB Regimens Phase 2/Phase 3
Active, not recruiting NCT03470233 - Post Marketing Registry to Assess Usage, Safety and Effectiveness of Deltyba Tablets in Korean Patients With MDR-TB
Recruiting NCT03830671 - The Effect of 18-month Regimen Containing 6 Anti-tuberculosis Drugs for Patients With MDR-TB N/A
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