Drug Interaction Study Between Linezolid and Clarithromycin in Tuberculosis Patients
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|ClinicalTrials.gov Identifier: NCT01521364|
Recruitment Status : Completed
First Posted : January 30, 2012
Results First Posted : July 1, 2013
Last Update Posted : July 1, 2013
|Condition or disease||Intervention/treatment||Phase|
|Multidrug-resistant Tuberculosis Extensively Drug-resistant Tuberculosis||Drug: Addition of different doses of clarithromycin.||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Pharmacokinetic Effect of Clarithromycin on the AUC0-12h of Linezolid in Multidrug-resistant and Extensively Drug-resistant Tuberculosis (MDR/XDR-TB) Patients|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||November 2012|
0mg, 250mg, and 500mg claritromycin
Patients receive 300mg linezolid twice a day during entire study. After one week, 250mg claritromycin once daily is added for a duration of two weeks.
After another two weeks, 250mg claritromycin is replaced by 500mg claritromycin once daily for another two weeks.
After this, there is a wash-out period of one week during which no claritromycine is administered.
Drug: Addition of different doses of clarithromycin.
At week 1, 250mg clarithromycin once a day will be added to linezolid therapy during two weeks.
At week 3, 500mg clarithromycin once a day will be added to linezolid therapy during to weeks.
Other Name: Clarithromycin, 250/500mg (Pharmachemie) RVG 029081/029082
- Area Under the Time Concentration Curve (AUC0-12h) of Linezolid in Plasma After Addition of 0mg, 250mg, or 500mg Clarithromycin (CLA). [ Time Frame: At week 1 (baseline), week 3 (250mg clarithromycin), and week 5(500mg clarithromycin). ]
The AUCs of linezolid will be measured at 3 time points after addition of 3 different clarithromycin dosages.
Samples were obtained before doseing and 1h, 2h, 3h, 4h, 8h, and 12h after administration of linezolid (and claritromycin depending on the period).
- Linezolid (LIN) and Clarithromycin (CLA) Pharmacokinetic Parameters, e.g. Tmax, Cmax, Cmin, T1/2, Cl. [ Time Frame: At week 1 (baseline), week 3 (250mg clarithromycin), and week 5 (500mg clarithromycin) and week 6 (baseline). ]
- Number of Patients With Adverse Events (AEs) [ Time Frame: Up to week 6 ]To assess short-term safety and tolerability when combining linezolid (LIN) with clarithromycin (CLA) by monitoring AEs, i.e. gastro-intestinal effects, hyperlactatemia, haematological abnormalities and neuropathy.
- Pharmacokinetic Parameters, e.g. Tmax, T1/2, Cmax, Cmin, Cl, of Anti-TB Drugs That Are Co-administered as Part of the Continued Standard Care. [ Time Frame: At week 1 (baseline), week 3 (250mg clarithromycin) and week 5 (500mg clarithromycin) ]
- Area Under the Time Concentration Curve (AUC0-12h) of Linezolid in Saliva. [ Time Frame: At week 3 (after co-administration of 250mg clarithromycin) ]The data will be used to clinically validate the analysis linezolid in saliva as surrogate marker for linezolid in plasma.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01521364
|Tuberculosis Center Beatrixoord|
|Haren, Groningen, Netherlands|
|Principal Investigator:||Jan-Willem C Alffenaar, PhD, PharmD||University Medical Center Groningen|