NCT04235361

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
3 countries

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 21, 2020

Completed
12 months until next milestone

Study Start

First participant enrolled

January 15, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
Last Updated

November 10, 2020

Status Verified

November 1, 2020

Enrollment Period

6 months

First QC Date

January 16, 2020

Last Update Submit

November 9, 2020

Conditions

Ebola Virus DiseaseMalariaTyphoid FeverDengue FeverChikungunya FeverYellow Fever

Outcome Measures

Primary Outcomes (1)

  • Recombinase polymerase amplifictaion test result

    The test results will be provided in Time of Threshold (TT) values

    The test result will be provided on the same day as the sample is received. The test procedure takes up to 3hours

Study Arms (1)

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

Interventions

Differential RPA testsDIAGNOSTIC_TEST

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.

EVD patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

See above

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Québec City-Université Laval Hospital Research Centre's CRI Infectious Disease Research Centre

Québec, Canada

Location

National Institute for Biomedical Research (NIBR) Democratic Republic of the Congo

Kinshasa, Democratic Republic of the Congo

Location

University of Göttingen

Göttingen, Germany

Location

Institute Pasteur de Dakar, Senegal

Dakar, Senegal

Location

Biospecimen

Retention: SAMPLES WITH DNA

Diagnostic extracts produced at ETC are sent and stored at the INRB in Kinshasa

MeSH Terms

Conditions

Hemorrhagic Fever, EbolaMalariaTyphoid FeverDengueChikungunya FeverYellow Fever

Condition Hierarchy (Ancestors)

Hemorrhagic Fevers, ViralRNA Virus InfectionsVirus DiseasesInfectionsFiloviridae InfectionsMononegavirales InfectionsProtozoan InfectionsParasitic DiseasesMosquito-Borne DiseasesVector Borne DiseasesSalmonella InfectionsEnterobacteriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesArbovirus InfectionsFlavivirus InfectionsFlaviviridae InfectionsAlphavirus InfectionsTogaviridae Infections

Study Officials

  • Manfred Weidmann, PhD

    m.w.weidmann@stir.ac.uk

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Manfred Weidmann, PhD

CONTACT

+441786467873m.w.weidmann@stir.ac.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2020

First Posted

January 21, 2020

Study Start

January 15, 2021

Primary Completion

June 30, 2021

Study Completion

July 30, 2021

Last Updated

November 10, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)DE(1)CA(1)