Adapting LFI for Melioidosis

Melioidosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03528265
• Other study ID #: Pro00091842
• Status: Completed
• Start date: June 21, 2018
• Est. completion date: January 8, 2019

Study information

• Verified date: July 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 8, 2019
• Est. primary completion date: January 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months and older

Eligibility

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

Related Conditions & MeSH terms

• Melioidosis

Intervention

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

Locations

Country	Name	City	State
Malaysia	Kapit Hospital	Kapit	Sarawak

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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