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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

Page last updated: August 23, 2015

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