NCT02045160

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 17, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 24, 2014

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

August 4, 2014

Status Verified

July 1, 2014

Enrollment Period

3.9 years

First QC Date

January 17, 2014

Last Update Submit

July 31, 2014

Conditions

Pneumocystis Jirovecii Pneumonia

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Sulfamethoxazole-trimethoprim treatment

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who are treated in the National Taiwan University Hospital

You may qualify if:

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

You may not qualify if:

  • patients who are under 20 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Taiwan University Hospital

Taipei, TW, 106, Taiwan

ACTIVE NOT RECRUITING

National Taiwan University Hospital

Taipei, TW, 106, Taiwan

RECRUITING

MeSH Terms

Conditions

Pneumonia, Pneumocystis

Condition Hierarchy (Ancestors)

Lung Diseases, FungalMycosesBacterial Infections and MycosesInfectionsPneumocystis InfectionsRespiratory Tract InfectionsPneumoniaLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Jin-Han Yang, Bachelor

CONTACT

0975-103-277r01451004@ntu.edu.tw

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
National Taiwan University Hospital

Study Record Dates

First Submitted

January 17, 2014

First Posted

January 24, 2014

Study Start

January 1, 2014

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

August 4, 2014

Record last verified: 2014-07

Locations

TW(2)