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Trial record 88 of 120 for:    CYCLOSERINE OR SEROMYCIN

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

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ClinicalTrials.gov Identifier: NCT01002170
Recruitment Status : Completed
First Posted : October 27, 2009
Last Update Posted : November 3, 2010
Sponsor:
Collaborator:
Centers for Disease Control, Taiwan
Information provided by:
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.


Condition or disease
Pulmonary Tuberculosis

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 Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Impact Factor Analysis of the Therapeutic Drug Monitoring of Oral 2nd Line Antituberculosis Agent, Cycloserine
Study Start Date : May 2009
Actual Primary Completion Date : June 2009
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis
Drug Information available for: Cycloserine




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Figuring out that factors causing different pharmacokinetics and the clinical outcomes in different Cycloserine level [ Time Frame: 2 and 6 hours after dosing ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Asia, Taiwan multidrug-resistant tuberculosis (MDR-TB) patients undergo Cycloserine treatment
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01002170


Locations
Taiwan
Taipei Medical University-Wan Fang Hospital
Taipei, Taiwan, 116
Sponsors and Collaborators
Taipei Medical University WanFang Hospital
Centers for Disease Control, Taiwan
Investigators
Principal Investigator: Ming-Chih Yu, M.D. Taipei Medical University-Wan Fang Hospital

Responsible Party: Ming -Chih Yu, M.D., Chief of Division of Chest Medicine, Taipei Medical University-Wan Fang Hospital
ClinicalTrials.gov Identifier: NCT01002170     History of Changes
Other Study ID Numbers: TB2NDCSTDMTW
First Posted: October 27, 2009    Key Record Dates
Last Update Posted: November 3, 2010
Last Verified: November 2010

Keywords provided by Taipei Medical University WanFang Hospital:
Tuberculosis
Cycloserine
Pharmacokinetics

Additional relevant MeSH terms:
Cycloserine
Tuberculosis
Tuberculosis, Pulmonary
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Antitubercular Agents
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Antibiotics, Antitubercular
Anti-Bacterial Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action