Status:
COMPLETED
Drug Interaction Study Between Linezolid and Clarithromycin in Tuberculosis Patients
Lead Sponsor:
University Medical Center Groningen
Conditions:
Multidrug-resistant Tuberculosis
Extensively Drug-resistant Tuberculosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 pos...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01521364
Start Date
December 1 2011
End Date
November 1 2012
Last Update
July 1 2013
Active Locations (1)
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1
Tuberculosis Center Beatrixoord
Haren, Provincie Groningen, Netherlands