Pharmacokinetic Study of Patients Who Undergo Cycloserine, a 2nd-line Antituberculosis Medicament
CSPK
The Impact Factor Analysis of the Therapeutic Drug Monitoring of Oral 2nd Line Antituberculosis Agent, Cycloserine
1 other identifier
observational
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2009
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 13, 2009
CompletedFirst Posted
Study publicly available on registry
October 27, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedNovember 3, 2010
November 1, 2010
1 month
July 13, 2009
November 1, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Figuring out that factors causing different pharmacokinetics and the clinical outcomes in different Cycloserine level
2 and 6 hours after dosing
Eligibility Criteria
Asia, Taiwan multidrug-resistant tuberculosis (MDR-TB) patients undergo Cycloserine treatment
You may qualify if:
- days and more of Cycloserine taking
- Asians
You may not qualify if:
- Cancer patients
- AIDS patients
- Combined AIDS-TB patients
- Pregnant subjects
- Anyone whose medical and medication records are unclear
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Taipei Medical University-Wan Fang Hospital
Taipei, 116, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ming-Chih Yu, M.D.
Taipei Medical University-Wan Fang Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 13, 2009
First Posted
October 27, 2009
Study Start
May 1, 2009
Primary Completion
June 1, 2009
Study Completion
May 1, 2010
Last Updated
November 3, 2010
Record last verified: 2010-11