The pharmacokinetic effect of clarithromycin on the AUC0-12h of linezolid in multidrug-resistant and extensively drug-resistant tuberculosis patients

Completed

• Conditions: TB; tuberculosis; 10028440

• Registration Number: NL-OMON35904
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2012-10-16
• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 7

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the increase in linezolid AUC0-12h due to a<br /><br>drug-drug interaction with clarithromycin after addition of 250 mg, and 500 mg<br /><br>clarithromycin compared to baseline (0 mg clarithromycin). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters consist of monitoring adverse events, i.e.<br /><br>gastro-intestinal side effect for clarithromycin, and hyperlactatemia,<br /><br>haematological abnormalities (thrombocytopenia or anaemia) and neuropathy for<br /><br>linezolid<br /><br>Also the (other) pharmacokinetic parameters of linezolid, clarithromycin and<br /><br>other anti-TB drugs, that are administered as a part of the continuous standard<br /><br>care.<br /><br>Clinical validation of the analysis of linezolid saliva.</p><br>