Drug Interaction Study Between Linezolid and Clarithromycin in Tuberculosis Patients

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2012-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Multidrug-resistant Tuberculosis Extensively Drug-resistant Tuberculosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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0mg, 250mg, and 500mg claritromycin

Patients receive 300mg linezolid twice a day during entire study. After one week, 250mg claritromycin once daily is added for a duration of two weeks.

After another two weeks, 250mg claritromycin is replaced by 500mg claritromycin once daily for another two weeks.

After this, there is a wash-out period of one week during which no claritromycine is administered.

Group Type OTHER

Addition of different doses of clarithromycin.

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Clarithromycin, 250/500mg (Pharmachemie) RVG 029081/029082

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No