Clinical trial NCT06153862: Africa Ready Malaria Screening
Official title: Africa Ready Malaria Screening
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Malaria
Lead sponsor: University of Ghana
Sponsor class: OTHER
Collaborators: name: Shai-Osudoku District Hospital
name: Kumasi Technical University
name: University of Rostock
name: University of Applied Sciences Bonn-Rhein-Sieg
name: Hochschule Aalen
First posted: 2023-12-01
Enrollment: 1640
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: MSP1-19 malaria antigen
timeFrame: one year
Secondary outcomes:
measure: Anti-MSP1-19 malaria antibody
timeFrame: three years
Other outcomes:
Locations:
city: Dodowa
country: Ghana
facility: Shai-Osudoku District Hospital
state: Outside North America
Study officials:
affiliation: Shai-Osudoku District Hospital
name: Adjei
role: STUDY_DIRECTOR
References: