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Africa Ready Malaria Screening

NCT ID: NCT06153862

Last Updated: 2023-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

1640 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-23

Study Completion Date

2025-09-30

Brief Summary

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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

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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

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Malaria

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Malaria patients

Malaria patients

Group Type ACTIVE_COMPARATOR

Immuno analytical assay

Intervention Type DIAGNOSTIC_TEST

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.

Non malaria donors

Healthy individuals (donors; controls)

Group Type ACTIVE_COMPARATOR

Immuno analytical assay

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shai-Osudoku District Hospital

UNKNOWN

Sponsor Role collaborator

Kumasi Technical University

UNKNOWN

Sponsor Role collaborator

University of Rostock

OTHER

Sponsor Role collaborator

University of Applied Sciences Bonn-Rhein-Sieg

UNKNOWN

Sponsor Role collaborator

Hochschule Aalen

UNKNOWN

Sponsor Role collaborator

University of Ghana

OTHER

Sponsor Role lead

Responsible Party

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Prof. Kwabena F.M. Opuni

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adjei

Role: STUDY_DIRECTOR

Shai-Osudoku District Hospital

Locations

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Shai-Osudoku District Hospital

Dodowa, Outside North America, Ghana

Site Status

Countries

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Ghana

Other Identifiers

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GHS-ERC: 009/06/22

Identifier Type: -

Identifier Source: org_study_id