MelioidosisNCT03048513
Clinical Presentation of Melioidosis in Head and Neck Region
An observational study of Melioidosis and Head and Neck Infection, run by Khon Kaen University at 1 site in Thailand.
Trial summary
Melioidosis in head and neck was observed including clinical presentation, diagnosis with titer, and result of treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Melioidosis, Head and Neck Infection
- What is being tested?
- Patient who presented with melioidosis in head and neck
- How many people
- 48 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jan 2017to 1 Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patients who has the pus culture from head and neck region positive with Burkholderia pseudomallei
Who cannot join
- No
Trial locations and contacts
1 site in 1 country.
Pornthep Kasemsiri, M.D. contact
Kanokkan Mahawerawat, M.D. contact
Thailand1 site, 1 recruiting
- Recruiting
Khon Kaen University
Khon Kaen, Changwat Khon Kaen, 40002
Pornthep Kasemsiri, M.D., Pkasemsiri99@gmail.com
About this study
Melioidosis in head and neck was observed including clinical presentation, diagnosis with titer, and result of treatment.
Read the detailed description
This research is retrospective study about five years ( Jan 2011- Oct 2016).
- Conditions
- Melioidosis, Head and Neck Infection
- Being tested
- Patient who presented with melioidosis in head and neck
- Keywords
- Melioidosis, Head and Neck, Clinical
- Medical subject headings
- Melioidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient who presented with melioidosis in head and neckOther
Investigators assess the patients who had the pus culture positive with Burkholderia pseudomallei.
What is being measured
The primary outcome is the main question the study is designed to answer.
Location of infection in head and neck as assess by clinical diagnosis
These results will be reported as single or multiple site infection in head and neck region.
Measured: 5 years
Secondary outcomes (2)
Diagnosis as confirm with pus culture
Assessing the correlation of melioid titer and culture by Pearson statistic
Measured: 5 years
Number of participants with successful treatment as assess by clinical presentation
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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study start1 Jan 2017
- Primary completion1 Jul 2017 (estimated)
- Study completion1 Jul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MelioidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pornthep Kasemsiri, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03048513
- Sponsor's protocol ID
- MEC007/59
- Status last verified
- Feb 2017
- First submitted
- 3 Feb 2017
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dance DA, Davis TM, Wattanagoon Y, Chaowagul W, Saiphan P, Looareesuwan S, Wuthiekanun V, White NJ. Acute suppurative parotitis caused by Pseudomonas pseudomallei in children. J Infect Dis. 1989 Apr;159(4):654-60. doi: 10.1093/infdis/159.4.654.
PubMed 2926159
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Presentation of Melioidosis in Head and Neck Region
- ClinicalTrials.gov ID
- NCT03048513
- Acronym / sponsor ID
- MEC007/59
- Conditions
- Melioidosis, Head and Neck Infection
- Keywords
- Melioidosis, Head and Neck, Clinical
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jul 2017 (estimated)
- Study completion
- 1 Jul 2017 (estimated)
- First posted
- 9 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Melioidosis in head and neck was observed including clinical presentation, diagnosis with titer, and result of treatment.
Detailed description
This research is retrospective study about five years ( Jan 2011- Oct 2016).
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients who has the pus culture from head and neck region positive with Burkholderia pseudomallei
Key exclusion criteria (1 listed)
- No
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient who presented with melioidosis in head and neckInvestigators assess the patients who had the pus culture positive with Burkholderia pseudomallei. | Other | – |
Primary outcome
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.
2 secondary outcomes
Diagnosis as confirm with pus culture
Time frame: 5 years
Number of participants with successful treatment as assess by clinical presentation
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2017.
- Results publication: PubMed 2926159Dance DA, Davis TM, Wattanagoon Y, Chaowagul W, Saiphan P, Looareesuwan S, Wuthiekanun V, White NJ. Acute suppurative parotitis caused by Pseudomonas pseudomallei in children. J Infect Dis. 1989 Apr;159(4):654-60. doi: 10.1093/infdis/159.4.654.
- Individual participant dataSharing planned: Undecided
Related trials for Melioidosis
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Environment, Pathogens, and Host Interactions in Melioidosis
Melioidosis
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Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective
Dengue, Chikungunya
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pornthep Kasemsiri, M.D. contact
Kanokkan Mahawerawat, M.D. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melioidosis and Head and Neck Infection, run by Khon Kaen University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pornthep Kasemsiri, M.D. (Pkasemsiri99@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Location of infection in head and neck as assess by clinical diagnosis (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03048513, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2017.