- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03048513
Clinical Presentation of Melioidosis in Head and Neck Region
February 8, 2017 updated by: Pornthep Kasemsiri, Khon Kaen University
Melioidosis in head and neck was observed including clinical presentation, diagnosis with titer, and result of treatment.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
This research is retrospective study about five years ( Jan 2011- Oct 2016).
Study Type
Observational
Enrollment (Anticipated)
48
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Khon Kaen, Thailand, 40002
- Recruiting
- Khon Kaen University
-
Contact:
- Pornthep Kasemsiri, M.D.
- Email: Pkasemsiri99@gmail.com
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients who has the pus culture from head and neck region positive with Burkholderia pseudomallei.
Furthermore, these pateints were received treatment at Mukdahan Hospital, Thailand.
Description
Inclusion Criteria:
- Patients who has the pus culture from head and neck region positive with Burkholderia pseudomallei
Exclusion Criteria:
- No
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Location of infection in head and neck as assess by clinical diagnosis
Time Frame: 5 years
|
These results will be reported as single or multiple site infection in head and neck region.
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diagnosis as confirm with pus culture
Time Frame: 5 years
|
Assessing the correlation of melioid titer and culture by Pearson statistic
|
5 years
|
|
Number of participants with successful treatment as assess by clinical presentation
Time Frame: 5 years
|
These results will be evaluated as remission or recurrent. The remission mean that fever or pus collection is subside and no presentation with melioidosis again in 5 years. The recurrent mean that participants will present with clinical melioidosis again in 5 years |
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the 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 (Actual)
January 1, 2017
Primary Completion (Anticipated)
July 1, 2017
Study Completion (Anticipated)
July 1, 2017
Study Registration Dates
First Submitted
February 3, 2017
First Submitted That Met QC Criteria
February 7, 2017
First Posted (Estimate)
February 9, 2017
Study Record Updates
Last Update Posted (Actual)
February 10, 2017
Last Update Submitted That Met QC Criteria
February 8, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MEC007/59
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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