TB tuberculosis
Conditions
Interventions
Patients will receive 300 mg LIN orally twice a day during six weeks. At week 1
the steady state area under the curve (AUC) 0-12h will be calculated by
obtaining samples via an intravenous catheter
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age >=18 years old - Signed informed consent - Diagnosis of MDR-TB confirmed with standard microbiological criteria (culture-based, molecular or both)
Exclusion criteria
Exclusion criteria: The criteria for exclusion are based on the contra indication as mentioned in the SPC texts of LIN and CLA. - 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-glycoprotein inhibitors/inducers, e.g. amiodarone, verapamil, digoxin, tipranavir/ritonavir, lovastatin, tariquidar, itraconazole, dipyridamol, erythromycin, ritonavir, quinidine. A pharmacist will check the co-medication of each patient for drug-drug interactions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is the increase in linezolid AUC0-12h due to a drug-drug interaction with clarithromycin after addition of 250 mg, and 500 mg clarithromycin compared to baseline (0 mg clarithromycin). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters consist of monitoring adverse events, i.e. gastro-intestinal side effect for clarithromycin, and hyperlactatemia, haematological abnormalities (thrombocytopenia or anaemia) and neuropathy for linezolid Also the (other) pharmacokinetic parameters of linezolid, clarithromycin and other anti-TB drugs, that are administered as a part of the continuous standard care. Clinical validation of the analysis of linezolid saliva. | — |
Countries
Netherlands
Outcome results
None listed