Pharmacokinetic Study of Patients Who Undergo Cycloserine, a 2nd-line Antituberculosis Medicament
Information source: Taipei Medical University WanFang Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pulmonary Tuberculosis
Phase: N/A
Status: Completed
Sponsored by: Taipei Medical University WanFang Hospital Official(s) and/or principal investigator(s): Ming-Chih Yu, M.D., Principal Investigator, Affiliation: Taipei Medical University-Wan Fang Hospital
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.
Clinical Details
Official title: The Impact Factor Analysis of the Therapeutic Drug Monitoring of Oral 2nd Line Antituberculosis Agent, Cycloserine
Study design: Observational Model: Case-Only, Time Perspective: Prospective
Primary outcome: Setting up a suggested treating concentration fitting for Asian (Taiwanese) and developing the therapeutic drug monitoring protocols in Taiwan
Secondary outcome: Figuring out 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
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Taipei Medical University-Wan Fang Hospital, Taipei 116, Taiwan
Additional Information
Starting date: May 2009
Last updated: November 1, 2010
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