Mobile Point of Care Diagnostic Testing for Ebola Virus Disease in DRC (MobEboDRC)
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|ClinicalTrials.gov Identifier: NCT04235361|
Recruitment Status : Not yet recruiting
First Posted : January 21, 2020
Last Update Posted : November 10, 2020
A mobile suitcase laboratory for EBOV point-of-care (POC) detection at Ebola treatment centers was successfully implemented in Guinea during the large Ebola virus disease (EVD) outbreak in West-Africa 2014-2015.
It was shown that isothermal amplification (Recombinase Polymerase Amplification (RPA)) could be efficiently used to test suspect EVD cases and local teams were trained in and successfully deployed with this fast method.
In the frame of this project we want to train teams in DRC and expand RPA testing capacity to the differentials recommended by the WHO. Existing RPA assays for all parameters will be included into a multistrip for simultaneous use. This will be integrated with a simple biosafe extraction method.
Implementing this approach and testing in the ongoing EVD outbreak will provide teams in DRC with response capacity for future EVD outbreaks.
|Condition or disease||Intervention/treatment|
|Ebola Virus Disease Malaria Typhoid Fever Dengue Fever Chikungunya Fever Yellow Fever||Diagnostic Test: Differential RPA tests|
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Mobile Point of Care Diagnostic Testing for Ebola Virus Disease in DRC|
|Estimated Study Start Date :||January 15, 2021|
|Estimated Primary Completion Date :||June 30, 2021|
|Estimated Study Completion Date :||July 30, 2021|
The samples of all subjects (male, female, adults and children) meeting the WHO case definition of "suspected" and "probable" EVD case eligible for real time RT-PCR assay, according to the currently used case definition in DRC, will be tested by differential RPA.
Diagnostic Test: Differential RPA tests
The mobile diagnostic suitcases will be deployed at Ebola Treatment centres in DRC. Samples of patients refered for diagnostic testing will be tested by PCR by existing diagnostic teams, and will be additionally tested by the mobile suitcase laboratory using differential RPA tests for 6 parameters.
- Recombinase polymerase amplifictaion test result [ Time Frame: The test result will be provided on the same day as the sample is received. The test procedure takes up to 3hours ]The test results will be provided in Time of Threshold (TT) values
Biospecimen Retention: Samples With DNA
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): NCT04235361
|Contact: Manfred Weidmann, PhDemail@example.com|
|Québec City-Université Laval Hospital Research Centre's CRI Infectious Disease Research Centre|
|Congo, The Democratic Republic of the|
|National Institute for Biomedical Research (NIBR) Democratic Republic of the Congo|
|Kinshasa, Congo, The Democratic Republic of the|
|Contact: Sheila Makiala, MD +243998216400 firstname.lastname@example.org|
|Contact: Placide Mbala +243822851584 email@example.com|
|University of Göttingen|
|Institute Pasteur de Dakar, Senegal|
|Principal Investigator:||Manfred Weidmann, PhDfirstname.lastname@example.org|