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

NCT ID: NCT01002170

Last Updated: 2010-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-05-31

Brief Summary

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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

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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.

Conditions

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Pulmonary Tuberculosis

Keywords

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Tuberculosis Cycloserine Pharmacokinetics

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centers for Disease Control, Taiwan

OTHER_GOV

Sponsor Role collaborator

Taipei Medical University WanFang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Taipei Medical University-Wan Fang Hospital

Principal Investigators

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Ming-Chih Yu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University-Wan Fang Hospital

Locations

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Taipei Medical University-Wan Fang Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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TB2NDCSTDMTW

Identifier Type: -

Identifier Source: org_study_id