Clinical Presentation of Melioidosis in Head and Neck Region

Melioidosis Clinical Trial

Official title:

Clinical Presentation of Melioidosis in Head and Neck Region

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03048513
• Other study ID #: MEC007/59
• Status: Recruiting
• Phase: N/A
• First received: February 3, 2017
• Last updated: February 8, 2017
• Start date: January 1, 2017
• Est. completion date: July 1, 2017

Study information

• Verified date: February 2017
• Source: Khon Kaen University
• Contact: Pornthep Kasemsiri, M.D.
• Email: Pkasemsiri99[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

This research is retrospective study about five years ( Jan 2011- Oct 2016).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: July 1, 2017
• Est. primary completion date: July 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Related Conditions & MeSH terms

• Head and Neck Infection
• Melioidosis

Intervention

Other:
• Patient who presented with melioidosis in head and neck
Investigators assess the patients who had the pus culture positive with Burkholderia pseudomallei.

Locations

Country	Name	City	State
Thailand	Khon Kaen University	Khon Kaen

Sponsors (1)

Lead Sponsor	Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Diagnosis as confirm with pus culture	Assessing the correlation of melioid titer and culture by Pearson statistic	5 years
Secondary	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	5 years