An observational study in Pulmonary Tuberculosis, sponsored by Taipei Medical University WanFang Hospital. Completed at 1 site in Taiwan. Per ClinicalTrials.gov, last updated 2010-11-03.
Sponsored by Taipei Medical University WanFang Hospital · Observational
In all treatments of tuberculosis, the second-line drugs are usually less effective but have more drug toxicity than the first-line ones. For the multidrug-resistant tuberculosis (MDR-TB) patients, who are resistant to the major first-line anti-tuberculosis drugs such as Rifampin and Isoniazid, the second-line agents, like Cycloserine in this research, are in frequent use. Taking patients' safety into consideration, therapeutic drug monitoring of Cycloserine has been listed as a routine examination during the tuberculosis treatment and established a suggested Cycloserine serum concentration of 20\~35 mcg/mL.
While this suggested drug concentration was set up, it isn't suitable to all races in the world. The investigators plan to develop the therapeutic drug monitoring protocols and a suggested treating concentration fitting for Asian (Taiwanese). In addition, through this research, the investigators can also realize that factors causing different pharmacokinetics and the clinical outcomes in different Cycloserine level.
In all treatments of tuberculosis, the second-line drugs are usually less effective but have more drug toxicity than the first-line ones. For the multidrug-resistant tuberculosis (MDR-TB) patients, who are resistant to the major first-line anti-tuberculosis drugs such as Rifampin and Isoniazid, the second-line agents, like Cycloserine in this research, are in frequent use. Taking patients' safety into consideration, therapeutic drug monitoring of Cycloserine has been listed as a routine examination during the tuberculosis treatment and established a suggested Cycloserine serum concentration of 20\~35 mcg/mL.
While this suggested drug concentration was set up, it isn't suitable to all races in the world. The investigators plan to develop the therapeutic drug monitoring protocols and a suggested treating concentration fitting for Asian (Taiwanese). In addition, through this research, the investigators can also realize that factors causing different pharmacokinetics and the clinical outcomes in different Cycloserine level.
1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.
This study's planned enrollment of 30 is below the median of 250 across 421 observational studies indexed under Tuberculosis.
Browse Tuberculosis studies →Taipei Medical University WanFang Hospital is the lead sponsor of 196 studies on the registry; 19 are open to participants now.
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Asia, Taiwan multidrug-resistant tuberculosis (MDR-TB) patients undergo Cycloserine treatment
Exclusion Criteria:
Setting up a suggested treating concentration fitting for Asian (Taiwanese) and developing the therapeutic drug monitoring protocols in Taiwan
Time frame: 2 and 6 hours after dosing
Figuring out that factors causing different pharmacokinetics and the clinical outcomes in different Cycloserine level
Time frame: 2 and 6 hours after dosing
This study is completed, as verified in Nov 2010. You cannot join it, but the record below documents what was studied.
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Taipei Medical University WanFang Hospital