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

Pneumocystis Jirovecii Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02045160
• Other study ID #: 201312090RINC
• Status: Recruiting
• Phase: N/A
• First received: January 17, 2014
• Last updated: July 31, 2014
• Start date: January 2014
• Est. completion date: December 2017

Study information

• Verified date: July 2014
• Source: National Taiwan University Hospital
• Contact: Jin-Han Yang, Bachelor
• Phone: 0975-103-277
• Email: r01451004[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pneumocystis Jirovecii Pneumonia
• Pneumonia, Pneumocystis

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei	TW
Taiwan	National Taiwan University Hospital	Taipei	TW

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	High performance liquid chromatography for drug plasma concentration	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	Yes