- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02045160
A Pharmacokinetic and Pharmacogenetic Study in Patients Receiving Sulfamethoxazole-trimethoprim Therapy
July 31, 2014 updated by: National Taiwan University Hospital
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.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
1000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jin-Han Yang, Bachelor
- Phone Number: 0975-103-277
- Email: r01451004@ntu.edu.tw
Study Locations
-
-
TW
-
Taipei, TW, Taiwan, 106
- Active, not recruiting
- National Taiwan University Hospital
-
Taipei, TW, Taiwan, 106
- Recruiting
- National Taiwan University Hospital
-
Contact:
- Jin-Han Yang
- Email: r01451004@ntu.edu.tw
-
Principal Investigator:
- Shu-Wen Lin
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients who are treated in the National Taiwan University Hospital
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
Sulfamethoxazole-trimethoprim treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Participants will be followed for the duration of the treatment course, an expected average of 21 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Anticipated)
December 1, 2017
Study Completion (Anticipated)
December 1, 2017
Study Registration Dates
First Submitted
January 17, 2014
First Submitted That Met QC Criteria
January 22, 2014
First Posted (Estimate)
January 24, 2014
Study Record Updates
Last Update Posted (Estimate)
August 4, 2014
Last Update Submitted That Met QC Criteria
July 31, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201312090RINC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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