A Pharmacokinetic and Pharmacogenetic Study in Patients Receiving Sulfamethoxazole-trimethoprim Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02045160
Recruitment Status : Unknown
Verified July 2014 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : January 24, 2014
Last Update Posted : August 4, 2014
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
In this study, we aim to investigate the incidence of the adverse reactions, the effectiveness and the gene polymorphism associated with the plasma level of sulfamethoxazole-trimethoprim and their metabolites (including N4-acetyl-sulfamethoxazole, sulfamethoxazole hydroxylamine and sulfamethoxazole-nitroso). And we also aim to investigate the factors associated with the sulfamethoxazole-trimethoprim induced acute psychosis.

Condition or disease
Pneumocystis Jirovecii Pneumonia

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Pharmacokinetic and Pharmacogenetic Study in Patients Receiving Sulfamethoxazole-trimethoprim Therapy
Study Start Date : January 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Sulfamethoxazole-trimethoprim treatment

Primary Outcome Measures :
  1. High performance liquid chromatography for drug plasma concentration [ Time Frame: Participants will be followed for the duration of the treatment course, an expected average of 21 days ]
    The plasma concentration will not be measured until the patient's treatment course completed.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who are treated in the National Taiwan University Hospital

Inclusion Criteria:

  • males and females aged 20 years or older
  • using oral or intravenous form of sulfamethoxazole-trimethoprim

Exclusion Criteria:

  • patients who are under 20 years of age

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 identifier (NCT number): NCT02045160

Contact: Jin-Han Yang, Bachelor 0975-103-277

National Taiwan University Hospital Active, not recruiting
Taipei, TW, Taiwan, 106
National Taiwan University Hospital Recruiting
Taipei, TW, Taiwan, 106
Contact: Jin-Han Yang   
Principal Investigator: Shu-Wen Lin         
Sponsors and Collaborators
National Taiwan University Hospital

Responsible Party: National Taiwan University Hospital Identifier: NCT02045160     History of Changes
Other Study ID Numbers: 201312090RINC
First Posted: January 24, 2014    Key Record Dates
Last Update Posted: August 4, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Pneumonia, Pneumocystis
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Lung Diseases, Fungal
Pneumocystis Infections
Trimethoprim, Sulfamethoxazole Drug Combination
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2C8 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Bacterial Agents