Adapting LFI for Melioidosis

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

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.

Study Overview

• Status: Completed
• Conditions: Melioidosis
• Intervention / Treatment: Device: Lateral flow immunoassay

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Malaysia
  • Sarawak
    • Kapit, Sarawak, Malaysia
      • Kapit Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients evaluated at Kapit Hospital experiencing melioidosis-like symptoms.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with melioidosis-like symptoms admitted to Kapit Hosp	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

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

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Gregory C Gray, MD, MPH, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2018
• Primary Completion (Actual): January 8, 2019
• Study Completion (Actual): January 8, 2019

Study Registration Dates

• First Submitted: May 7, 2018
• First Submitted That Met QC Criteria: May 16, 2018
• First Posted (Actual): May 17, 2018

Study Record Updates

• Last Update Posted (Actual): August 1, 2019
• Last Update Submitted That Met QC Criteria: July 31, 2019
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: validation; lateral flow immunoassay
• Additional Relevant MeSH Terms: Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Burkholderia Infections; Melioidosis
• Other Study ID Numbers: Pro00091842

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes