ARMS: Africa Ready Malaria Screening

• Sponsor: University of Ghana (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT06153862
• Collaborator: Shai-Osudoku District Hospital (Other), Kumasi Technical University (Other), University of Rostock (Other), University of Applied Sciences Bonn-Rhein-Sieg (Other), Hochschule Aalen (Other)
• Enrollment: 1,640
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 35.3
• Patients Per Site Per Month: 46.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Malaria	Diagnostic Test: Immuno analytical assay	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 1640 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Africa Ready Malaria Screening
• Actual Study Start Date: Sep 23, 2022
• Anticipated Primary Completion Date: Sep 1, 2024
• Anticipated Study Completion Date: Sep 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Malaria patients Malaria patients	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.
Active Comparator: Non malaria donors Healthy individuals (donors; controls)	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.

Outcome Measures

Primary Outcome Measures

1. 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

1. Anti-MSP1-19 malaria antibody [three years]

   Number of participants with antiMSP1-19 malaria antibody as assessed by a lateral flow test kit.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shai-Osudoku District Hospital	Dodowa	Outside North America	Ghana	GAR

Sponsors and Collaborators

• University of Ghana
• Shai-Osudoku District Hospital
• Kumasi Technical University
• University of Rostock
• University of Applied Sciences Bonn-Rhein-Sieg
• Hochschule Aalen

Investigators

• Study Director: Adjei, Shai-Osudoku District Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Prof. Kwabena F.M. Opuni, Associate Professor, University of Ghana
• ClinicalTrials.gov Identifier: NCT06153862
• Other Study ID Numbers: GHS-ERC: 009/06/22
• First Posted: Dec 1, 2023
• Last Update Posted: Dec 1, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Malaria

Study Results

No Results Posted as of Dec 1, 2023