NCT01521364

Drug Interaction Study Between Linezolid and Clarithromycin in Tuberculosis Patients

The Pharmacokinetic Effect of Clarithromycin on the AUC0-12h of Linezolid in Multidrug-resistant and Extensively Drug-resistant Tuberculosis (MDR/XDR-TB) Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Future patients might benefit from a combination of linezolid (LIN) and clarithromycin (CLA) in the treatment of Multidrug-resistant and Extensively Drug-resistant Tuberculosis (MDR/XDR-TB) due to possible synergistic activity as shown in in vitro experiments in different Mycobacteria strains. The investigators observed increased LIN serum levels in three cases after combining LIN and CLA of which the investigators described one in a case report (Bolhuis et al). The investigators suggest to conduct a prospective pharmacokinetic study in MDR- and XDR-TB patients to quantify the above described interaction between LIN and CLA.

Conditions

• Multidrug-resistant Tuberculosis
• Extensively Drug-resistant Tuberculosis

Interventions

Type	Name	Description
DRUG	Addition of different doses of clarithromycin.	At week 1, 250mg clarithromycin once a day will be added to linezolid therapy during two weeks. At week 3, 500mg clarithromycin once a day will be added to linezolid therapy during to weeks.

Timeline

• Start date: 2011-12-01
• Primary completion: 2012-10-01
• Completion: 2012-11-01
• First posted: 2012-01-30
• Last updated: 2013-07-01
• Results posted: 2013-07-01

Locations

1 site across 1 country: Netherlands