Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201501001002391 Date of Approval: 19/01/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Biocartis Clinical Performance Evaluation Study in Sierra Leone of the Biocartis Idylla System with the Rapid Ebola Virus Triage Test
Official scientific title Biocartis Clinical Performance Evaluation Study in Sierra Leone of the Biocartis Idylla System with the Rapid Ebola Virus Triage Test
Brief summary describing the background and objectives of the trial Biocartis developed a Rapid Ebola Virus Triage Test in response to the current Ebola Outbreak. This test runs on Biocartis¿ fully integrated molecular diagnostic system referred to as Idylla. This new molecular diagnostic solution can be best described as a ¿lab-in-box¿ which automates all steps from sample-to-result and it can be run by any healthcare professional in the laboratory or even in the field. Hence, this is an outbreak solution that is sustainable and suitable for future outbreaks in Africa. The hands-on time required to perform the test is only 2 minutes and comprises four simple steps: scanning the disposable Ebola cartridge, scanning the patient sample (or inserting the sample ID), loading the (whole) blood sample in the cartridge and placing the cartridge in the instrument. A brochure containing more information about the Idylla system is included in the accompanying e-mail.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Ebola,Infections and Infestations
Sub-Disease(s) or condition(s) being studied Ebola
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 02/02/2015
Actual trial start date 09/02/2015
Anticipated date of last follow up 03/08/2015
Actual Last follow-up date 31/07/2015
Anticipated target sample size (number of participants) 300
Actual target sample size (number of participants) 300
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Non-randomised N/A N/A Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group RT-PCR Rapid Ebola Diagnostic test N/A 6 MONTHS Non invasive 300 Dose Comparison
Control Group RT-PCR Rapid Ebola Diagnostic Test N/A 6 months Non-invasive: Patients not presenting any signs and symptoms of Ebola Virus Disease 150 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion criteria: ¿ Samples can be used for investigational purposes according to the applicable laws ¿ Whole blood samples of patients with symptoms of Ebola infection Exclusion criteria: ¿ Patient objected to providing his/her sample to third parties for research purposes or samples not released for research purposes Non Ebola , Non Suspect patient 18 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 19/01/2015 Sierra Leone Ethic Review Committee
Ethics Committee Address
Street address City Postal code Country
Connaught Hospital Freetown Sierra Leone
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Percentage positive and the negative agreemtn will be included in the calculation n/a
Primary Outcome Percentage overall agreement as defined by the percentage of valid Ebola Test results in agreement with the valid Ebola Reference results n/a
Primary Outcome Percentage of overall agreement at the first level i.e. with respect to the dichotomous level Ebola Virus detected or not detected and at the second level, i.e. with respect to the specific Ebola virus strain (Zaire or Sudan). Confidence interval on the diagnostic agreement will be used to evaluate the study acceptance criteria n/a
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
ETC Port Loko Port Loko Sierra Leone
FUNDING SOURCES
Name of source Street address City Postal code Country
Biocartis Biocartis NV ¿ Generaal de Wittleaan 11B 3 ¿ 2800 Mechelen ¿ KBO 0827475227 www.biocartis.com Palo Alto Belgium
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Biocartis Generaal De Wittelaan 11 B3 Mechelen 2800 Belgium Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Dr Mohamed Samai Freetown Sierra Leone
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Serge Blaise Emaleu dremaleu@gmail.com +23278910391 Rock Condos, Imatt,Leicester Peak Sam Sumana Drive
City Postal code Country Position/Affiliation
Freetown Freetown Sierra Leone Senior Clinical Research Scientist
Role Name Email Phone Street address
Public Enquiries Luc Van Hove Luc Van Hove lvhove@biocartis.com +32476960 I 53 Generaal De Wittelaan 11 B3
City Postal code Country Position/Affiliation
Mechelen 2800 Belgium Chief Medical Officer
Role Name Email Phone Street address
Scientific Enquiries Mohamed Samai dhmsamai@yahoo.com +23278841262 Freetown -COMAHS
City Postal code Country Position/Affiliation
Freetown Sierra Leone Co Principal Investigator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information