inezolid and clarithromycin drug-interaction study in multidrug-resistant and extensively drug-resistant tuberculosis patients.

Recruiting

Conditions: -'drug interaction'- linezolid- clarithromycin- multidrug-resistant and extensively drug-resistant tuberculosis (MDR/XDR-TB)in dutch/ in het nederlands:- geneesmiddelinteractie- linezolid- claritromycine- multidrug-resistente and extensieve drug-resistente tuberculose (MDR/XDR-TBC)

Registration Number: NL-OMON24566

Lead Sponsor: niversity Medical Center GroningenA.t.t.n. Prof Dr JGW Kosterink, Department of Hospital and Clinical PharmacyP.O. Box 30.001; 9700 RB Groningen,The NetherlandsTel: +31 50 361 4071Fax: +31 50 361 4087Email: j.g.w.kosterink@umcg.nl

Brief Summary: Bolhuis MS, Van Altena R, Uges DR, van der Werf TS, Kosterink JG, Alffenaar JW. Clarithromycin significantly increases linezolid serum concentrations. Antimicrob Agents Chemother 2010.

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 7

Inclusion Criteria

1. Age ≥ 18 years old;

2. Signed informed consent;

Exclusion Criteria

1. Hypersensitivity to linezolid, clarithromycin, erythromycin, or any macrolide antibiotics, or any of the excipients of linezolid or clarithromycin;

2. Concomitant use with astemizole, cisapride, ergotamine derivatives
(dihydroergotamine, ergotamine), monoamine oxidase inhibitors (phenelzine,
isocarboxazid, selegiline, or moclobemide), pimozide, or terfenadine;

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
1. Secondary study parameters consist of monitoring adverse events, i.e. gastro-intestinal side effect for clarithromycin, and<br>hyperlactatemia, haematological abnormalities (thrombocytopenia or anaemia) and neuropathy for linezolid;<br /><br>2. Also the (other) pharmacokinetic parameters of linezolid, clarithromycin and other anti-TB drugs, that are administered as a part of the continuous standard care;<br /><br>3. Clinical validation of the analysis of linezolid.saliva.