Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04299412
Other study ID # FE005
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 28, 2019
Est. completion date September 30, 2020

Study information

Verified date November 2023
Source Foundation for Innovative New Diagnostics, Switzerland
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 104
Est. completion date September 30, 2020
Est. primary completion date July 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


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

Locations

Country Name City State
Australia Menzies School of Health Research Darwin

Sponsors (1)

Lead Sponsor Collaborator
Foundation for Innovative New Diagnostics, Switzerland

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 2 months
See also
  Status Clinical Trial Phase
Completed NCT03080623 - Ultrasound-based Diagnostic Model for Differentiating Malignant Breast Lesion From Benign Lesion
Completed NCT03073746 - Google Health Search Trial N/A
Recruiting NCT04568967 - TB-CAPT EXULTANT - HIV N/A
Completed NCT05120167 - Strategies for Endocervical Canal Investigation in Women With Abnormal Screening Cytology and Negative Colposcopy N/A
Completed NCT04168983 - Impact of Sophrology on the Pain Felt During a Bone Marrow Aspiration and Biopsy N/A
Recruiting NCT05194527 - The Detrimental Course of Acute Intestinal Ischemia
Not yet recruiting NCT04035174 - Evaluation of the Diagnosis Performances of DEC LTS-2 Skin Patch for Onchocerciasis in Central Africa N/A
Recruiting NCT05043662 - UroCAD Assay Combined With Computed Tomography Urography and Urine Cytology for UTUC Diagnosis.
Recruiting NCT04056273 - Assess the Use of rEBUS With a Guide Sheath to Increase Transbronchial Lung Biopsy Yield Rate N/A
Completed NCT03193671 - Evaluation and Implementation of New Biomarkers and Algorithms for Diagnosis of Ovarian Cysts/Tumors in the Pelvis N/A
Recruiting NCT03210311 - Pre-existing Factors, Early Detection and Early Treatment of Breast Cancer Related Lymphedema N/A
Active, not recruiting NCT05185388 - Socioeconomic Inequalities in the Diagnosis and Treatment of Colon and Ovarian Cancer in England Between 2016-2017
Completed NCT04212286 - Comparing the Diagnostic Efficiencies of CEUS and EOB-MRI in Patients With High Risk of HCC N/A
Completed NCT04109625 - Preliminary Validation of an in Vitro Diagnosis-medical Device for Hepatitis B Screening N/A
Not yet recruiting NCT05064566 - Evaluation of Caries Detection Methods
Recruiting NCT03347630 - Pre-operative MRI of Esophagus Cancer N/A
Completed NCT05604482 - CXCR4-PET/CT for Diagnosing Giant Cell Arteritis N/A
Completed NCT04541160 - Ultra-low Dose Chest Computed Tomography: a Rule-out Tool for Community-acquired Pneumonia
Completed NCT04315207 - Breaking Potentially Bad News in Lung Cancer Workup: Telephone Versus In-person Breaking of Final Diagnosis N/A
Completed NCT04788966 - Evaluation of an Innovative Speech-enabled Translator in Emergency Settings