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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

Tracking Information
First Submitted Date March 5, 2020
First Posted Date March 6, 2020
Last Update Posted Date April 3, 2020
Actual Study Start Date October 28, 2019
Actual Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 5, 2020)
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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Diagnostic Accuracy of the DPP II Assay
Official Title Diagnostic Accuracy of the DPP Fever Panel II Asia and the DPP Micro Reader
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Acute Febrile Illness
  • Melioidosis
  • Diagnoses Disease
Intervention 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
Study Groups/Cohorts
  • Melioidosis cases
    serum samples collected from patients with B. pseudomallei positive cultures
    Intervention: Device: DPP Fever Panel II assay
  • Non-melioidosis cases
    serum samples collected from patients with B. pseudomallei negative cultures
    Intervention: Device: DPP Fever Panel II assay
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 5, 2020)
104
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 31, 2020
Actual Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Sonia Arafah, PhD +41 22 749 19 28 ext +41227491928 Sonia.Arafah@finddx.org
Contact: Sabine Dittrich, PhD Sabine.Dittrich@finddx.org
Listed Location Countries Australia
Removed Location Countries  
 
Administrative Information
NCT Number NCT04299412
Other Study ID Numbers FE005
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Foundation for Innovative New Diagnostics, Switzerland
Study Sponsor Foundation for Innovative New Diagnostics, Switzerland
Collaborators Not Provided
Investigators Not Provided
PRS Account Foundation for Innovative New Diagnostics, Switzerland
Verification Date April 2020