Multidrug-resistant and extensively drug-resistant tubeculosis (MDR/XDR-TB) MedDRA version: 14.0 Level: LLT Classification code 10043148 Term: TB System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Zyvoxid
Pharmaceutical Form: Coated tablet
CAS Number: 165800-03-3
Other descriptive name: LINEZOLID
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 600
Sponsors
University Medical Center Groningen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The criteria for inclusion are: - Age =18 years old - Signed informed consent - Diagnosis of MDR/XDR-TB confirmed with standard microbiological criteria (culture-based, molecular or both) Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 8 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8
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: o LIN o CLA, erythromycin, or any macrolide antibiotics o any of the excipients of LIN or CLA. - 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 |
|---|---|
| Main Objective: The primary objective is to quantify the LIN AUC0-12h increase after addition of 250 mg, or 500 mg CLA compared to baseline (0 mg CLA). ;Secondary Objective: The secondary objectives are to describe the LIN and CLA pharmacokinetic parameters and to assess short-term safety and tolerability when combining LIN with CLA by monitoring adverse events (AEs), i.e. gastro-intestinal effects, hyperlactatemia, haematological abnormalities (thrombocytopenia or anaemia) and neuropathy. Also to describe observational pharmacokinetic parameters of anti-TB drugs that are co-administered as part of the continued standard care.;Primary end point(s): The main study parameter is the increase in LIN AUC0-12h due to a drug-drug interaction with CLA after addition of 250 mg, and 500 mg CLA compared to baseline (0 mg CLA). Adverse events will be monitored, i.e. gastro-intestinal side effect for CLA, and peripheral neuropathy and anaemia for LIN. ;Timepoint(s) of evaluation of this end point: Evaluation will take place after the study, from six weeks after inclusion. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Also (other) pharmacokinetic parameters of linezolid, clarithromycin, and other anti-TB drugs, that are administered as a part of the continuous standard care, will be determined.;Timepoint(s) of evaluation of this end point: Evaluation will take place after the study, from six weeks after inclusion. | — |
Countries
Netherlands
Contacts
Public Contactdr. J.G.W. Kosterink
University Medical Center Groningen
Outcome results
None listed