EUCTR2011-000513-39-NL进行中（未招募）不适用
The pharmacokinetic effect of clarithromycin on the AUC0-12h of linezolid in multidrug-resistant and extensively drug-resistant tuberculosis patients - LIN/CLA interaction study in MDR/XDR-TB patients
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 8
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •The criteria for exclusion are based on the contra indication as mentioned in the SPC texts of LIN and CLA.
- •- Hypersensitivity to:
- •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.
研究者
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inezolid and clarithromycin drug-interaction study in multidrug-resistant and extensively drug-resistant tuberculosis patients.-'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)NL-OMON24566niversity 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.nl7
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