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

Completed

• Conditions: Pulmonary Tuberculosis

• Registration Number: NCT01002170
• Lead Sponsor: Taipei Medical University WanFang Hospital

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.

Study Timeline

• Study Start: 2009-05
• Primary Completion: 2009-06
• Study First Submitted: 2009-07-13
• Study First Submitted QC: 2009-10-25
• Study First Posted: 2009-10-27
• Study Completion: 2010-05
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-01
• Last Update Posted: 2010-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Setting up a suggested treating concentration fitting for Asian (Taiwanese) and developing the therapeutic drug monitoring protocols in Taiwan	2 and 6 hours after dosing

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Taipei Medical University-Wan Fang Hospital; 🇨🇳 Taipei, Taiwan