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Drug Interaction Study Between Linezolid and Clarithromycin in Tuberculosis Patients

Information source: University Medical Center Groningen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multidrug-resistant Tuberculosis; Extensively Drug-resistant Tuberculosis

Intervention: Addition of different doses of clarithromycin. (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University Medical Center Groningen

Official(s) and/or principal investigator(s):
Jan-Willem C Alffenaar, PhD, PharmD, Principal Investigator, Affiliation: University Medical Center Groningen


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 Details

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

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

Primary outcome: Area Under the Time Concentration Curve (AUC0-12h) of Linezolid in Plasma After Addition of 0mg, 250mg, or 500mg Clarithromycin (CLA).

Secondary outcome:

Linezolid (LIN) and Clarithromycin (CLA) Pharmacokinetic Parameters, e.g. Tmax, Cmax, Cmin, T1/2, Cl.

Number of Patients With Adverse Events (AEs)

Pharmacokinetic Parameters, e.g. Tmax, T1/2, Cmax, Cmin, Cl, of Anti-TB Drugs That Are Co-administered as Part of the Continued Standard Care.

Area Under the Time Concentration Curve (AUC0-12h) of Linezolid in Saliva.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Age ≥18 years old

- Signed informed consent

- Diagnosis of MDR/XDR-TB confirmed with standard microbiological criteria

(culture-based, molecular or both)

- Treatment with linezolid 300mg twice daily per os.

Exclusion Criteria:

- Hypersensitivity to: linezolid, clarithromycin, erythromycin, or any macrolide

antibiotics, or any of the excipients of linezolid or clarithromycin.

- Concomitant use with astemizole, cisapride, ergotamine derivatives

(dihydroergotamine, ergotamine), monoamine oxidase inhibitors (phenelzine, isocarboxazid, selegiline, or moclobemide), pimozide, or terfenadine.

- Pregnancy or breast-feeding.

- Hypokalemia

- Concomitant use of other P-gp inhibitors/inducers, e. g. amiodarone, verapamil,

digoxin, tipranavir/ritonavir, lovastatin, tariquidar, itraconazole, dipyridamol, erythromycin, ritonavir, quinidine.

Locations and Contacts

Tuberculosis Center Beatrixoord, Haren, Groningen, Netherlands
Additional Information

Starting date: December 2011
Last updated: May 27, 2013

Page last updated: August 23, 2015

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