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.: PACTR202407803149023 Date of Approval: 29/07/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Clinical evaluation of Malaria rapid antigen test
Official scientific title Clinical evaluation of Malaria rapid diagnostic test kits
Brief summary describing the background and objectives of the trial According to the World Malaria Report 2015, there were 210 million cases of malaria globally in 2015 (uncertainty range 149-303 million) and 438,000 malaria deaths (range 236,000-635,000), representing a decrease in malaria cases and deaths of 37% and 60% since 2,000, respectively. The protozoal parasites that cause malaria are from Plasmodium falciparum, vivax, ovale and malariae with the first two species causing the most infectious worldwide. Classic symptoms of malaria include fever, headache, chills, vomiting, shivering and convulsions. In some rare forms of P. falciparum, the patient may present with delirium or coma. Several anemia is often attributed to the cause of death from malaria. Accurate and prompt diagnosis of malaria is of utmost importance due to the morbidity associated with the other malarial forms. Rapid diagnostic test is an ideal diagnostic tool for malaria diagnosis in that it can provide a rapid determination if the patient is infected with malaria allowing for accurate treatment and improved outcomes. STANDARDTM Q Malaria P.f Ag Test 2.0, a reliable and sensitive screening test, would enhance the accuracy of the diagnosis of malaria infection and thus make clinical treatment decision effectively.This study aims to assess the performance of the hs-Malaria test in accordance with the World Health Organization (WHO) Prequalification: Target Product Profile for TSS3 Malaria Rapid Diagnostic Tests. Malaria continues to pose a significant public health burden globally, necessitating accurate and timely diagnostic tools for effective management and control. Rapid diagnostic tests (RDTs) have emerged as valuable tools for malaria diagnosis, particularly in resource-limited settings. This study seeks to evaluate the performance characteristics of the hs-Malaria test against the WHO standards to determine its suitability for widespread use.To assess the performance of STANDARDTM Q hs- Malaria P.f/P.v Ag Test and STANDARDTM Q hs- Malaria P.f Ag Test
Type of trial Observational
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/07/2024
Actual trial start date
Anticipated date of last follow up 31/08/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 2000
Actual target sample size (number of participants) 2000
Recruitment status Active, not 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
Single Group Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group STANDARD Q hs Malaria RDT NA 20 mins this study does not require an intervention. This is a prospective study that aims to establish the clinical sensitivity and specificity of the STANDARDTM Q hs- Malaria P.f/P.v Ag Test and STANDARDTM Q hs- Malaria P.f Ag Test on venous as well as capillary whole blood. 2000
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Presenting at the study site with fever or a history of fever during the preceding 48-hours Freely agreeing to participate by providing informed consent (and assent, as applicable Presence of symptoms and signs of severe illness and/or central nervous system infections as defined by WHO guidelines. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Child: 6 Year-12 Year,Infant: 13 Month(s)-24 Month(s),Middle Aged: 45 Year(s)-64 Year(s),Preschool Child: 2 Year-5 Year 1 Year(s) 64 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 04/10/2023 Noguchi Memorial Institute for Medical Research
Ethics Committee Address
Street address City Postal code Country
Akilagpa Sawyerr road Accra lg581 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Relative diagnostic sensitivity and specificity shall be determined for each claimed specimen type. The RDT will be read 20 mins after testing
Secondary Outcome RDT positivity rate 20 minutes
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ewim Polyclinic Gov Rowe Rd Cape Coast Ghana
Mpree health center cape coast Cape coast Ghana
Obom Polyclinic Obom Accra Ghana
Kofi Kwei CHPS Kofi Kwei Accra Ghana
Kings Medical Center Kumbungu Kunbungu Ghana
Yendi Municipal Hospital Yendi Yendi Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
SD Biosensor 16, Deogyeong-daero, 1556beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do 16690 souel Korea, Democratic People's Republic of
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor SD Biosensor Deogyeong-daero, 1556beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do 16690 Seoul Korea, Democratic People's Republic of Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Linda Amoah lamoah@noguchi.ug.edu.gh +233266025054 Off Akilagpa sawyeer road
City Postal code Country Position/Affiliation
Legon Ghana Associate professor of immunology imunology department NMIMR
Role Name Email Phone Street address
Public Enquiries Baafour Gyewu baafuor.gyewu@codixgroup.com +233267768730 Afua Matei Cres
City Postal code Country Position/Affiliation
Accra Ghana Country representative
Role Name Email Phone Street address
Scientific Enquiries Hansol Ju jhs5398@sdbiosensor.com 00823180650322 Giheung ICT Valley 58-1
City Postal code Country Position/Affiliation
Seoul Korea, Democratic People's Republic of Clinical affairs Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Yes: There is a plan to make all collected IPD and related data dictionaries available Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol “Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.” ““Access to trial IPD can be requested by qualified individuals engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact the PI at lamoah@noguchi.ug.edu.gh
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