drugset / Trial / NCT01521364

Drug Interaction Study Between Linezolid and Clarithromycin in Tuberculosis Patients

NCT01521364

Phase 4 Completed 7 enrolled University Medical Center Groningen
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2011-12
Primary completion
2012-10
Completion
2012-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Clarithromycin Small molecule 250 mg
Subject Clarithromycin Small molecule 500 mg