Pharmacokinetic Study of Patients Who Undergo Cycloserine, a 2nd-line Antituberculosis Medicament

Overview

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.

Full Title of Study: “The Impact Factor Analysis of the Therapeutic Drug Monitoring of Oral 2nd Line Antituberculosis Agent, Cycloserine”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 2009

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.

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • Figuring out that factors causing different pharmacokinetics and the clinical outcomes in different Cycloserine level
    • Time Frame: 2 and 6 hours after dosing

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Taipei Medical University WanFang Hospital
  • Collaborator
    • Centers for Disease Control, Taiwan
  • Provider of Information About this Clinical Study
    • Ming -Chih Yu, M.D., Chief of Division of Chest Medicine, Taipei Medical University-Wan Fang Hospital
  • Overall Official(s)
    • Ming-Chih Yu, M.D., Principal Investigator, Taipei Medical University-Wan Fang Hospital

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