NCT03528265

Adapting LFI for Melioidosis

Adapting a Rapid Lateral Flow Burkholderia Pseudomallei Immunoassay in Sarawak, Malaysia

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 6 Months
• Healthy volunteers: Not accepted

Summary

Towards the goal of reducing melioidosis, this study will help clinicians in Sarawak to diagnose and understand the causes and risk factors for melioidosis. The data will help the clinicians to provide faster test results and better clinical care. The investigator's laboratory efforts will supplement available diagnostics by adding a new, easier-to-use test involving lateral flow immunoassay to rapidly detect Burkholderia pseudomallei, a bacterium causing melioidosis. The study aims to study up to 400 patients with melioidosis-like symptoms who are admitted to Kapit Hospital, Sarawak, Malaysia. No participants will be enrolled from other sites. The study will also examine the demographic, behavioral and occupational risk factors associated with hospital admissions to understand any existing associations between these variables and melioidosis prevalence.

Conditions

• Melioidosis

Interventions

Type	Name	Description
DEVICE	Lateral flow immunoassay	Biospecimens of patients with melioidosis-like symptoms will be tested with lateral flow immunoassay to detect Burkholderia pseudomallei, bacterium causing melioidosis

Timeline

• Start date: 2018-06-21
• Primary completion: 2019-01-08
• Completion: 2019-01-08
• First posted: 2018-05-17
• Last updated: 2019-08-01

Locations

1 site across 1 country: Malaysia

Regulatory

• FDA-regulated device study