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Mobile Point of Care Diagnostic Testing for Ebola Virus Disease in DRC (MobEboDRC)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04235361
Recruitment Status : Not yet recruiting
First Posted : January 21, 2020
Last Update Posted : November 10, 2020
Sponsor:
Collaborators:
Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
Institut Pasteur de Dakar
University of Göttingen
Centre de Recheche du Centre Hospitalier Université Laval
Information provided by (Responsible Party):
University of Stirling

Brief Summary:

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

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
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


Group/Cohort Intervention/treatment
EVD patients
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.




Primary Outcome Measures :
  1. 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
Diagnostic extracts produced at ETC are sent and stored at the INRB in Kinshasa


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
See above
Criteria

Inclusion criteria

  • 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.
  • For the prospective evaluation, oral informed consent from the patient/legal guardian will be requested for eligibility to participate in the study

Exclusion criteria:

  • inability to provide consent, samples or condition that could jeopardize the subject's safety.

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): NCT04235361


Contacts
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Contact: Manfred Weidmann, PhD +441786467873 m.w.weidmann@stir.ac.uk

Locations
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Canada
Québec City-Université Laval Hospital Research Centre's CRI Infectious Disease Research Centre
Québec, Canada
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    shemakiala@yahoo.fr   
Contact: Placide Mbala    +243822851584    mbalaplacide@gmail.com   
Germany
University of Göttingen
Göttingen, Germany
Senegal
Institute Pasteur de Dakar, Senegal
Dakar, Senegal
Sponsors and Collaborators
University of Stirling
Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
Institut Pasteur de Dakar
University of Göttingen
Centre de Recheche du Centre Hospitalier Université Laval
Investigators
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Principal Investigator: Manfred Weidmann, PhD m.w.weidmann@stir.ac.uk
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Responsible Party: University of Stirling
ClinicalTrials.gov Identifier: NCT04235361    
Other Study ID Numbers: 992770
RIA2018EF-2089 ( Other Identifier: EDCTP grant number )
First Posted: January 21, 2020    Key Record Dates
Last Update Posted: November 10, 2020
Last Verified: November 2020
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: No
Additional relevant MeSH terms:
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Typhoid Fever
Virus Diseases
Dengue
Hemorrhagic Fever, Ebola
Chikungunya Fever
Yellow Fever
Fever
Body Temperature Changes
Arbovirus Infections
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral
Filoviridae Infections
Mononegavirales Infections
Salmonella Infections
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Alphavirus Infections
Togaviridae Infections