CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 7 enrolled
Drug / intervention
Addition of different doses of clarithromycin.drug
Likely dose
Addition of different doses of clarithromycin. 250mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01521364
NCT01521364Phase 4Completed
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The Pharmacokinetic Effect of Clarithromycin on the AUC0-12h of Linezolid in Multidrug-resistant and Extensively Drug-resistant Tuberculosis (MDR/XDR-TB) Patients

University Medical Center Groningen·interventional·Posted Jan 30, 2012·Updated Jul 1, 2013

In Brief

A Phase 4 clinical trial evaluating Addition of different doses of clarithromycin. for Multidrug-resistant Tuberculosis and Extensively Drug-resistant Tuberculosis. Completed, enrolled 7 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultidrug-resistant Tuberculosis, Extensively Drug-resistant Tuberculosis
CountriesNetherlands
Collaborators--

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 30, 2012
Enrollment StartDec 1, 2011
Primary CompletionOct 1, 2012
Study CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 14.4 years ago

Interventions

Addition of different doses of clarithromycin.drug

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.