NCT03048513

Brief Summary

Melioidosis in head and neck was observed including clinical presentation, diagnosis with titer, and result of treatment.

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
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 3, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 9, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

February 10, 2017

Status Verified

February 1, 2017

Enrollment Period

6 months

First QC Date

February 3, 2017

Last Update Submit

February 8, 2017

Conditions

Keywords

MelioidosisHead and NeckClinical

Outcome Measures

Primary Outcomes (1)

  • 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.

    5 years

Secondary Outcomes (2)

  • Diagnosis as confirm with pus culture

    5 years

  • Number of participants with successful treatment as assess by clinical presentation

    5 years

Interventions

Investigators assess the patients who had the pus culture positive with Burkholderia pseudomallei.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Patients who has the pus culture from head and neck region positive with Burkholderia pseudomallei

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Khon Kaen University

Khon Kaen, Changwat Khon Kaen, 40002, Thailand

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Melioidosis

Condition Hierarchy (Ancestors)

Burkholderia InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Central Study Contacts

Pornthep Kasemsiri, M.D.

CONTACT

Kanokkan Mahawerawat, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 3, 2017

First Posted

February 9, 2017

Study Start

January 1, 2017

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

February 10, 2017

Record last verified: 2017-02

Locations