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.: PACTR202308652843585 Date of Approval: 10/08/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Clinical Diagnostic Performance Evaluation of a Measles Rapid Test in Senegal
Official scientific title Clinical Diagnostic Performance Evaluation of an Anti-Measles IgM Lateral Flow Immunochromatographic Assay for Outbreak Detection and Surveillance in Senegal
Brief summary describing the background and objectives of the trial Measles is a highly contagious but vaccine preventable infection that caused 200,000 deaths in 2019. Robust surveillance systems are a key pillar of the WHO strategy for elimination in all regions. Rapid diagnostic tests (RDT) that are accurate, simple, easy to use and interpret, and robust when stored at ambient temperature would be useful tools for the early detection of measles outbreaks and to support the overall surveillance capacity in outbreak-prone countries. This is a prospective diagnostic evaluation study of a professional use measles rapid diagnostic test (RDT), designed to assess the performance (sensitivity and specificity) of the RDT (on capillary blood, serum and oral fluid) for measles case confirmation by healthcare workers for the purposes of outbreak detection and national surveillance. Primary objective: To determine the clinical performance (sensitivity and specificity) of the RDT for measles case confirmation using capillary blood by healthcare workers under field conditions compared to the current laboratory reference standard (using anti-measles IgM in serum by Enzyme Immunoassay (EIA) and/or virus detection by RT PCR of nasopharyngeal swabs or oral fluid). Secondary objectives: 1. To determine the clinical performance of the RDT for measles case confirmation in serum by laboratory personnel compared to the current laboratory reference standard. 2. To determine the inter-reader agreement of the RDT for measles case confirmation under field conditions. 3. To determine the clinical performance of the RDT for measles case confirmation using oral fluid collected under field conditions, compared to the current laboratory reference standard. 4. To assess the ease of use of the RDT by healthcare workers using capillary blood and serum and other end-user feedback (including health staff for sampling procedures, instructions, packaging and storage).
Type of trial Observational
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations,Paediatrics
Sub-Disease(s) or condition(s) being studied Measles
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/11/2023
Actual trial start date
Anticipated date of last follow up 01/07/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 850
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
NCT05860920 ClinicalTrials.gov
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
Single Group Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Novel RDT plus normal surveillance practice N/A N/A Testing of all suspected measles cases by: Novel RDT on capillary blood, serum +/- oral fluid IgM detection by ELISA +/- PCR on throat swab or oral fluid (reference standard/normal surveillance practice) 850
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients (all ages) presenting to participating health centres: - For whom confirmatory diagnostic testing is currently indicated as per the national surveillance protocol - With clinical signs and symptoms consistent with the WHO suspected measles case definition including: History of fever, or observed fever (>37.5C) at presentation and a (non-vesicular) maculopapular rash; or clinically suspected measles - ≤ 28 days after the onset of a rash - Who if <18 years of age, have written, informed consent from their legal guardian (and verbally assent if more than 7 years old) - Who if more than 18 years, give written, informed consent - Withdrawal of consent or assent as described above, at any time. - Unsuccessful venous blood sampling after a maximum of 3 attempts, or a serum sample is no longer available for any reason. - Clinical signs or symptoms requiring immediate referral/transfer of the patient to another site or centre, and/or for whom participation would involve a delay of urgent clinical interventions or investigations - Clinical signs or symptoms that may be exacerbated by blood draw or upper respiratory sampling (e.g. stridor or severe respiratory distress) - Prior recruitment to the study 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Infant: 0 Month-23 Month,Infant: 1 Month-23 Month,Middle Aged: 45 Year(s)-64 Year(s),New born: 0 Day-1 Month,Preschool Child: 2 Year-5 Year 0 Year(s) 120 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
No 23/07/2023 COMITE NATIONAL D ETHIQUE POUR LA RECHERCHE EN SANTE
Ethics Committee Address
Street address City Postal code Country
RUE AIME CESEAIRE, FANN RESIDENCE Dakar B.P. 4024 Senegal
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Sensitivity and specificity of the RDT using capillary blood, serum and oral fluid, compared to the current laboratory reference standard using anti-measles IgM in serum by Enzyme Immuno Assay (EIA) and/or RT PCR of throat swabs or oral fluid, with 95% exact (Clopper Pearson) confidence intervals D0 - at recruitment
Secondary Outcome Inter-reader agreement of the RDT for measles case confirmation by healthcare workers under field conditions D0 - at recruitment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Institut Pasteur de Dakar 36 Avenue Pasteur Dakar B.P. 220 Senegal
FUNDING SOURCES
Name of source Street address City Postal code Country
Bill and Melinda Gates Foundation 500 5th Ave N Seattle WA 98109 United States of America
La Fondation MSF 34 AV. JEAN JAURES Paris 75019 France
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Institut Pasteur de Dakar 36 Avenue Pasteur Dakar B.P. 220 Senegal Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
EPICENTRE 34 AV. JEAN JAURES Paris 75019 France
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Cheikh Tidiane Diagne cheikhtidiane.diagne@pasteur.sn +221338399200 36 Avenue Pasteur
City Postal code Country Position/Affiliation
Dakar B.P.220 Senegal Head of DIATROPIX
Role Name Email Phone Street address
Principal Investigator Boly Diop diopboly@yahoo.fr +221338694227 Rue FN 20
City Postal code Country Position/Affiliation
Dakar Senegal Head of Epidemiological Surveillance Division of the Senegalese Ministry of Health
Role Name Email Phone Street address
Public Enquiries Elizabeth Fitchett elizabeth.fitchett@pasteur.sn +221775976273 36 Avenue Pasteur
City Postal code Country Position/Affiliation
Dakar B.P.220 Senegal DIATROPIX Clinical Studies Manager
Role Name Email Phone Street address
Scientific Enquiries Elizabeth Fitchett elizabeth.fitchett@pasteur.sn +221775976273 36 Avenue
City Postal code Country Position/Affiliation
Dakar B.P.220 Senegal DIATROPIX Clinical Studies Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The study protocol and anonymised data will be made available on reasonable request to principal investigators. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Within 12 months of the study completion date Upon reasonable request to the principal investigators
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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