NCT06153862

Africa Ready Malaria Screening

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,640 (actual)
• Sponsor: University of Ghana · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

This study aims to develop immuno-analytical assays for testing the titres of malaria antibodies in Ghanaian patients' and/or donors' sera using a recombinantly produced MSP119 fusion protein and/or MSP119-derived synthetic peptides as antigens.

Detailed description

In this study, immuno-analytical assays will be developed for determining the titres of malaria antibodies in sera of two groups (malaria patients and donors/healthy volunteers) using a recombinantly produced MSP119 fusion protein and/or MSP119-derived synthetic peptides as antigens. Individuals in the two groups presenting to Shai-Osudoku District hospital will be screened for signs and symptoms of malaria according to the WHO criteria. Those within the inclusion and exclusion criteria will be introduced to the study through informed consent for adults (18 years and over) or parents/guardians for children below 12 years and assent for adolescents between 12 and below 18 years, along with informed consent from their parents. Enrolled study participants' demographic data and vital signs will be captured electronically onto the CRF. Patients will have their clinical history and detailed physical examination done by the study clinicians and then be sent to the laboratory for investigations to confirm the malaria diagnosis. The results of patients will be communicated to the study clinician to commence the appropriate treatment. At the of the study, the results of all assays will be analyzed to determine if this test can be used to diagnose malaria infection.

Conditions

• Malaria

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Immuno analytical assay	The eluted antibodies will be used in immuno-analytical assays, such as ELISA or Western blot, or surface-coated bead-based screening platforms using either recombinantly produced MSP119 fusion protein or synthetic peptides derived from MSP119 as antigens according to standard protocols.

Timeline

• Start date: 2022-09-23
• Primary completion: 2024-09-01
• Completion: 2025-09-01
• First posted: 2023-12-01
• Last updated: 2023-12-01

Locations

1 site across 1 country: Ghana