NCT02658331

Brief Summary

The aim of our study is to assess the analytical and clinical performance of the FilmArray (FA) BioThreat-E test (BioFire®) for the diagnosis of Ebola virus disease in the field in Guinea versus conventional molecular techniques.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
156

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2015

Shorter than P25 for all trials

Status
completed

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

Study Start

First participant enrolled

March 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 18, 2016

Completed
Last Updated

January 18, 2016

Status Verified

January 1, 2016

Enrollment Period

4 months

First QC Date

January 6, 2016

Last Update Submit

January 14, 2016

Conditions

Ebola Virus Disease

Keywords

Ebola Virus DiseaseRapid DiagnosisPoint of careMolecular platform

Outcome Measures

Primary Outcomes (1)

  • Number of positive/negative patients for the detection of Ebola virus RNA with the BioThreat-E test performed on whole blood.

    Number of positive/negative patients for the detection of Ebola virus RNA with the BioThreat-E test in comparision with their Ebola Virus Disease status as defined based on the result of routine testing.

    Through study completion, an average of 6 months.

Secondary Outcomes (2)

  • Number of urine specimens positive/negative for the detection of Ebola virus RNA with the BioThreat-E test, in patients positive for Ebola Virus Disease based on routine testing, and able to provide a urine specimen.

    Through study completion, an average of 6 months.

  • Number of saliva specimens positive/negative for the detection of Ebola virus RNA with the BioThreat-E test, in patients positive for Ebola Virus Disease based on routine testing, and able to provide a saliva specimen.

    Through study completion, an average of 6 months.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients, male and female, older than 18, sent to Conakry or Coyah Ebola Treatment Centers for a suspicion of Ebola Virus Disease according to WHO criteria, and considered as eligible for Ebola routine diagnosis.

You may qualify if:

  • All patients, male and female, older than 18, sent to Conakry or Coyah Ebola Treatment Centers for a suspicion of EVD according to WHO criteria, and considered as eligible for Ebola routine diagnosis.
  • Ability to deliver a written informed consent

You may not qualify if:

  • Age below 18.
  • Inability to provide a consent
  • Inability to provide the blood specimens required for Ebola virus disease diagnosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Leski TA, Ansumana R, Taitt CR, Lamin JM, Bangura U, Lahai J, Mbayo G, Kanneh MB, Bawo B, Bockarie AS, Scullion M, Phillips CL, Horner CP, Jacobsen KH, Stenger DA. Use of the FilmArray System for Detection of Zaire ebolavirus in a Small Hospital in Bo, Sierra Leone. J Clin Microbiol. 2015 Jul;53(7):2368-70. doi: 10.1128/JCM.00527-15. Epub 2015 May 13.

    PMID: 25972415BACKGROUND

  • Southern TR, Racsa LD, Albarino CG, Fey PD, Hinrichs SH, Murphy CN, Herrera VL, Sambol AR, Hill CE, Ryan EL, Kraft CS, Campbell S, Sealy TK, Schuh A, Ritchie JC, Lyon GM 3rd, Mehta AK, Varkey JB, Ribner BS, Brantly KP, Stroher U, Iwen PC, Burd EM. Comparison of FilmArray and Quantitative Real-Time Reverse Transcriptase PCR for Detection of Zaire Ebolavirus from Contrived and Clinical Specimens. J Clin Microbiol. 2015 Sep;53(9):2956-60. doi: 10.1128/JCM.01317-15. Epub 2015 Jul 8.

    PMID: 26157148BACKGROUND

  • Weller SA, Bailey D, Matthews S, Lumley S, Sweed A, Ready D, Eltringham G, Richards J, Vipond R, Lukaszewski R, Payne PM, Aarons E, Simpson AJ, Hutley EJ, Brooks T. Evaluation of the Biofire FilmArray BioThreat-E Test (v2.5) for Rapid Identification of Ebola Virus Disease in Heat-Treated Blood Samples Obtained in Sierra Leone and the United Kingdom. J Clin Microbiol. 2016 Jan;54(1):114-9. doi: 10.1128/JCM.02287-15. Epub 2015 Nov 4.

    PMID: 26537445BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood Urine Saliva

MeSH Terms

Conditions

Hemorrhagic Fever, Ebola

Condition Hierarchy (Ancestors)

Hemorrhagic Fevers, ViralRNA Virus InfectionsVirus DiseasesInfectionsFiloviridae InfectionsMononegavirales Infections

Study Officials

  • Françoise Gay-Andrieu, MD-PhD

    BioMérieux

    STUDY CHAIR

  • N'Fally Magassouba, PhD

    Laboratoire des Fièvres Hémorragiques en Guinée - Université Gamal Nasser, Conakry.

    PRINCIPAL INVESTIGATOR

  • Mark Miller, MD-FRCPC

    BioMérieux

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2016

First Posted

January 18, 2016

Study Start

March 1, 2015

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

January 18, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share