Drug Interaction Study Between Linezolid and Clarithromycin in Tuberculosis Patients

Extensively Drug-resistant Tuberculosis Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Extensively Drug-resistant Tuberculosis
Multidrug-resistant Tuberculosis
Tuberculosis
Tuberculosis, Multidrug-Resistant

Clinical Trial Details

NCT number	NCT01521364
Study type	Interventional
Source	University Medical Center Groningen
Contact
Status	Completed
Phase	Phase 4
Start date	December 2011
Completion date	November 2012

View Details

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