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Adapting LFI for Melioidosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03528265
Recruitment Status : Completed
First Posted : May 17, 2018
Last Update Posted : August 1, 2019
Sponsor:
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment
Melioidosis Device: Lateral flow immunoassay

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Adapting a Rapid Lateral Flow Burkholderia Pseudomallei Immunoassay in Sarawak, Malaysia
Actual Study Start Date : June 21, 2018
Actual Primary Completion Date : January 8, 2019
Actual Study Completion Date : January 8, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Proportion of true positive [ Time Frame: up to 5 weeks ]
    Proportion of true positive of Bukholderia pseudomallei using rapid diagnostic tests compared to the results of qPCR, bacterial culture and Gram stain

  2. Proportion of true negative [ Time Frame: up to 5 weeks ]
    Proportion of true negative of Bukholderia pseudomallei using rapid diagnostic tests compared to the results of qPCR, bacterial culture and Gram stain


Secondary Outcome Measures :
  1. Statistical association between risk factors and test results [ Time Frame: up to 3 months ]
    conduct a survey to determine a statistical association between clinical risk factors and the test results combined


Biospecimen Retention:   Samples With DNA
DNA from blood samples


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients evaluated at Kapit Hospital experiencing melioidosis-like symptoms.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03528265


Locations
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Malaysia
Kapit Hospital
Kapit, Sarawak, Malaysia
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Gregory C Gray, MD, MPH Duke University
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03528265    
Other Study ID Numbers: Pro00091842
First Posted: May 17, 2018    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Duke University:
lateral flow immunoassay
validation
Additional relevant MeSH terms:
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Melioidosis
Burkholderia Infections
Gram-Negative Bacterial Infections
Bacterial Infections