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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT02045160
First received: January 17, 2014
Last updated: January 22, 2014
Last verified: January 2014
  Purpose

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
Pneumocystis Jiroveci Pneumonia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Pharmacokinetic and Pharmacogenetic Study in Patients Receiving Sulfamethoxazole-trimethoprim Therapy

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    The plasma concentration will not be measured until the patient's treatment course completed.


Estimated Enrollment: 1000
Study Start Date: January 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Sulfamethoxazole-trimethoprim treatment

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who are treated in the National Taiwan University Hospital

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02045160

Contacts
Contact: Jin-Han Yang, Bachelor 0975-103-277 r01451004@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Active, not recruiting
Taipei, TW, Taiwan, 106
National Taiwan University Hospital Recruiting
Taipei, TW, Taiwan, 106
Contact: Jin-Han Yang       r01451004@ntu.edu.tw   
Principal Investigator: Shu-Wen Lin         
Sponsors and Collaborators
National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02045160     History of Changes
Other Study ID Numbers: 201312090RINC
Study First Received: January 17, 2014
Last Updated: January 22, 2014
Health Authority: Taiwan: Research Ethics Committee

Additional relevant MeSH terms:
Pneumocystis Infections
Pneumonia
Pneumonia, Pneumocystis
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Lung Diseases, Fungal
Mycoses
Sulfamethoxazole
Trimethoprim
Trimethoprim-Sulfamethoxazole Combination
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Urinary
Renal Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2014