Africa Ready Malaria Screening

Not Applicable

Active, not recruiting

• Conditions: Malaria
• Interventions: Diagnostic Test: Immuno analytical assay

• Registration Number: NCT06153862
• Lead Sponsor: University of Ghana

Brief 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.

Study Timeline

• Study Start: 2022-09-23
• Study First Submitted: 2023-03-31
• Status Verified: 2023-11
• Study First Submitted QC: 2023-11-22
• Last Update Submitted: 2023-11-22
• Study First Posted: 2023-12-01
• Last Update Posted: 2023-12-01
• Primary Completion: 2024-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1640

Inclusion Criteria

• Patients with confirmed malaria (uncomplicated and complicated cases) are diagnosed by the national guidelines.
• Healthy individuals without confirmed malaria per the national guidelines.
• Adults and parents or guardians of children below 12 years willing to participate based on signed informed consent.
• Willing to give assent to adolescents between the ages of 12 and below 18 years.
• Willing to give a blood sample for the necessary investigations as explained in the informed consent.
• Willing to adhere to study procedures and a follow-up visit at the clinic, hospital, or health facility.

Exclusion Criteria

• Anyone refusing informed consent (or assent for adolescents) to be part of the study.
• Refusal to study procedures or giving of sample for the necessary investigations.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Malaria patients	Immuno analytical assay	Malaria patients
Non malaria donors	Immuno analytical assay	Healthy individuals (donors; controls)

Primary Outcome Measures

Name	Time	Method
MSP1-19 malaria antigen	one year	Number of participants with MSP1-19 malaria antigen as assessed by a lateral flow test kit.

Secondary Outcome Measures

Name	Time	Method
Anti-MSP1-19 malaria antibody	three years	Number of participants with antiMSP1-19 malaria antibody as assessed by a lateral flow test kit.

Trial Locations

Locations (1)

Shai-Osudoku District Hospital; 🇬🇭 Dodowa, Outside North America, Ghana