Adapting LFI for Melioidosis

NCT03528265 | Completed FDA Device

• 1 other identifier: Pro00091842
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Melioidosis

Keywords

lateral flow immunoassay; validation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Statistical association between risk factors and test results

  up to 3 months

Study Arms (1)

Patients with melioidosis-like symptoms admitted to Kapit Hosp

Device: Lateral flow immunoassay

Interventions

Lateral flow immunoassay DEVICE

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

Patients with melioidosis-like symptoms admitted to Kapit Hosp

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients evaluated at Kapit Hospital experiencing melioidosis-like symptoms.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Kapit Hospital

Kapit, Sarawak, Malaysia

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA from blood samples

MeSH Terms

Conditions

Melioidosis

Condition Hierarchy (Ancestors)

Burkholderia Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Gregory C Gray, MD, MPH

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2018
• First Posted: May 17, 2018
• Study Start: June 21, 2018
• Primary Completion: January 8, 2019
• Study Completion: January 8, 2019
• Last Updated: August 1, 2019

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)