Clinical trial NCT01002170: Pharmacokinetic Study of Patients Who Undergo Cycloserine, a 2nd-line Antituberculosis Medicament
Official title: The Impact Factor Analysis of the Therapeutic Drug Monitoring of Oral 2nd Line Antituberculosis Agent, Cycloserine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Tuberculosis
Keywords: Tuberculosis
Cycloserine
Pharmacokinetics
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control, Taiwan
First posted: 2009-10-27
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Asia, Taiwan multidrug-resistant tuberculosis (MDR-TB) patients undergo Cycloserine treatment

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 5 days and more of Cycloserine taking
* Asians

Exclusion Criteria:

* Cancer patients
* AIDS patients
* Combined AIDS-TB patients
* Pregnant subjects
* Anyone whose medical and medication records are unclear

Primary outcomes:
measure: Setting up a suggested treating concentration fitting for Asian (Taiwanese) and developing the therapeutic drug monitoring protocols in Taiwan
timeFrame: 2 and 6 hours after dosing
Secondary outcomes:
measure: Figuring out that factors causing different pharmacokinetics and the clinical outcomes in different Cycloserine level
timeFrame: 2 and 6 hours after dosing
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University-Wan Fang Hospital
Study officials:
affiliation: Taipei Medical University-Wan Fang Hospital
name: Ming-Chih Yu, M.D.
role: PRINCIPAL_INVESTIGATOR
References: