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Diagnostic Accuracy of the DPP II Assay

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ClinicalTrials.gov Identifier: NCT04299412
Recruitment Status : Recruiting
First Posted : March 6, 2020
Last Update Posted : April 3, 2020
Sponsor:
Information provided by (Responsible Party):
Foundation for Innovative New Diagnostics, Switzerland

Brief Summary:

Burkholderia pseudomallei is responsible for melioidosis, a disease that can present a range of signs and symptoms and can be treated by a specific drug regimen. Diagnosis of melioidosis is made by isolation of the bacteria from body fluids or tissues such as blood, skin or sputum. Although this is considered the gold standard, bacterial isolation has low diagnostic sensitivity, requires specific infrastructures (biosafety level 3 laboratories) and skilled staff that are not always available in LMICs. This may lead to inappropriate patient management and care.

Chembio, in partnership with FIND, has developed a multiplex lateral flow immunoassay (DPP® Fever Panel II Assay) that is able to detect antigens from common causes of febrile illnesses, included Burkholderia. FIND will conduct a laboratory study in Menzies Health School of Research to estimate the diagnostic accuracy of the DPP II Assay using retrospective samples that are positive for B. pseudomallei. Results will help in estimating the diagnostic accuracy of the assay for this pathogen.


Condition or disease Intervention/treatment
Acute Febrile Illness Melioidosis Diagnoses Disease Device: DPP Fever Panel II assay

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Study Type : Observational
Estimated Enrollment : 104 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Diagnostic Accuracy of the DPP Fever Panel II Asia and the DPP Micro Reader
Actual Study Start Date : October 28, 2019
Actual Primary Completion Date : November 30, 2019
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Group/Cohort Intervention/treatment
Melioidosis cases
serum samples collected from patients with B. pseudomallei positive cultures
Device: DPP Fever Panel II assay
Multiplex lateral flow immunoassay (DPP® Fever Panel II Assay) that is able to detect (i) antigens produced by Dengue, Zika, Chikungunya, Malaria and Burkholderia and (ii) IgM directed against Dengue, Zika, Chikungunya, Leptospira, Rickettsia typhi and Orientia tsutsugamushi. The assay comes with a reader that provides results interpretation to the operator in a few seconds

Non-melioidosis cases
serum samples collected from patients with B. pseudomallei negative cultures
Device: DPP Fever Panel II assay
Multiplex lateral flow immunoassay (DPP® Fever Panel II Assay) that is able to detect (i) antigens produced by Dengue, Zika, Chikungunya, Malaria and Burkholderia and (ii) IgM directed against Dengue, Zika, Chikungunya, Leptospira, Rickettsia typhi and Orientia tsutsugamushi. The assay comes with a reader that provides results interpretation to the operator in a few seconds




Primary Outcome Measures :
  1. Point estimates of sensitivity and specificity, with 95% confidence intervals, for the detection of B. pseudomallei by the DPP assay in comparison to a reference standard. [ Time Frame: 2 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Sera samples were collected between December 2014 and June 2018 for the "Assessment of a New Rapid Diagnostic Test for Melioidosis" study that was conducted by the Menzies School of Health Research in Darwin, Australia. Patients recruited during that study presented to the Royal Darwin Hospital (RDH) with suspicion of melioidosis and consented to provide blood samples and to allow their use in diagnostic studies. Their samples are stored at -80°C in the Tropical and Emerging Infectious Diseases laboratory at the Menzies School of Health Research.
Criteria

Inclusion Criteria:

- Samples that can be included in the trial must have been collected exclusively during the "Assessment of a New Rapid Diagnostic Test for Melioidosis" study (HREC 04/09) conducted by the Menzies School of Health Research. They must be well-characterized with confirmation of presence or absence of B. pseudomallei by bacterial culture.

Exclusion Criteria:

  • Samples with volume <120 µL
  • Samples collected during projects other than the HREC 04/09 project

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): NCT04299412


Contacts
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Contact: Sonia Arafah, PhD +41 22 749 19 28 ext +41227491928 Sonia.Arafah@finddx.org
Contact: Sabine Dittrich, PhD Sabine.Dittrich@finddx.org

Locations
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Australia
Menzies School of Health Research Recruiting
Darwin, Australia
Contact: Mark Mayo       Mark.Mayo@menzies.edu.au   
Principal Investigator: Bart Currie         
Sponsors and Collaborators
Foundation for Innovative New Diagnostics, Switzerland
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Responsible Party: Foundation for Innovative New Diagnostics, Switzerland
ClinicalTrials.gov Identifier: NCT04299412    
Other Study ID Numbers: FE005
First Posted: March 6, 2020    Key Record Dates
Last Update Posted: April 3, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Melioidosis
Burkholderia Infections
Gram-Negative Bacterial Infections
Bacterial Infections