Adapting LFI for Melioidosis

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Melioidosis

Intervention / Treatment
-----------------
* Device: Lateral flow immunoassay


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admitted to Kapit Hospital Fever more than 3 days and one or more of the following: Enlarged cervical, inguinal or axillary lymph nodes (greater than 3 cm in diameter), painless adenopathy or lymphadenitis or lymph node abscesses One or both sides glands involvement such as tender swelling over medial aspect of the lower eyelid of the lacrimal glands; submandibular glands, parotic glands Bedside scan with splenic or liver hypoechoic lesion (less than 2cm in diameter) Pneumonia not responding to 48 hours of first line antibiotics One or more joint pain with swelling Purplish vesicle or bullae mainly over the lower limbs, may resulting in ulcer after rupture Deep seated abscess or brain abscess or genitourinary abscess or osteomyelitis Severe sepsis patient with or without shock and/or with multiorgan involvement Exclusion Criteria: Have a clear alternative diagnosis other than melioidosis by a trained health care professional at the Kapit Hospital Have already been treated for melioidosis (e.g. received antibiotics before the start of the study) Are younger than 6 months of age

Ages Eligible for Study
-----------------
Minimum Age: 6 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with melioidosis-like symptoms admitted to Kapit Hosp<br> | Device: Lateral flow immunoassay<br>* Biospecimens of patients with melioidosis-like symptoms will be tested with lateral flow immunoassay to detect Burkholderia pseudomallei, bacterium causing melioidosis<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of true positive | Proportion of true positive of Bukholderia pseudomallei using rapid diagnostic tests compared to the results of qPCR, bacterial culture and Gram stain | up to 5 weeks | 
| Proportion of true negative | Proportion of true negative of Bukholderia pseudomallei using rapid diagnostic tests compared to the results of qPCR, bacterial culture and Gram stain | up to 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Statistical association between risk factors and test results | conduct a survey to determine a statistical association between clinical risk factors and the test results combined | up to 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lateral flow immunoassay, validation