MalariaARMSNCT06153862
Africa Ready Malaria Screening
A study testing Immuno analytical assay in people with Malaria, run by University of Ghana at 1 site in Ghana.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Immuno analytical assay
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,640 participants
- Where
- 1 siteGhana
- Study dates
- 23 Sep 2022to Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Immuno analytical assay
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immuno analytical assayDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Malaria patients | Active comparator | Malaria patients Receives: Diagnostic Test: Immuno analytical assay |
| Non malaria donors | Active comparator | Healthy individuals (donors; controls) Receives: Diagnostic Test: Immuno analytical assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
MSP1-19 malaria antigen
Number of participants with MSP1-19 malaria antigen as assessed by a lateral flow test kit.
Measured: one year
Secondary outcomes (1)
Anti-MSP1-19 malaria antibody
Number of participants with antiMSP1-19 malaria antibody as assessed by a lateral flow test kit.
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start23 Sep 2022
- Primary completionSep 2024 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,640 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ghana
- Sponsor type
- University, hospital or other
- Collaborators
- Shai-Osudoku District Hospital, Kumasi Technical University, University of Rostock, University of Applied Sciences Bonn-Rhein-Sieg, Hochschule Aalen
- Responsible party
- Principal investigator, Prof. Kwabena F.M. Opuni, University of Ghana
- Investigators
- Adjei, Study director, Shai-Osudoku District Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06153862
- Sponsor's protocol ID
- GHS-ERC: 009/06/22
- Acronym
- ARMS
- Status last verified
- Nov 2023
- First submitted
- 31 Mar 2023
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be deposited in Zenodo's open data repository service (CERN). Additionally, all datasets will be stored on external drives and in-house computers. The data will be deposited as soon as possible unless there is a legitimate reason and a decision has been agreed upon to protect the data. Before the upload of datasets, a unique DOI will be assigned, which will be stated in publications to direct readers to the primary datasets. Due to the public health interest of the outcome of this work, the datasets will be shared directly with relevant stakeholders for a wider public audience. There will be restricted datasets on the subject partaking in the study to protect their identity. This restriction will not affect the dissemination of the research outputs to the broader public. Although the datasets will be stored in the Zenodo repository for long-term preservation, the in-house datasets will be stored on an external drive for additional long-term benefit.
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Africa Ready Malaria Screening
- ClinicalTrials.gov ID
- NCT06153862
- Acronym / sponsor ID
- ARMS / GHS-ERC: 009/06/22
- Conditions
- Malaria
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,640 participants (actual)
- Lead sponsor
- University of GhanaUniversity, hospital or other
- Collaborators
- Shai-Osudoku District Hospital, Kumasi Technical University, University of Rostock, University of Applied Sciences Bonn-Rhein-Sieg, Hochschule Aalen
- Study start
- 23 Sep 2022 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 1 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Malaria patients | Active comparator | Diagnostic Test: Immuno analytical assayMalaria patients |
| Non malaria donors | Active comparator | Diagnostic Test: Immuno analytical assayHealthy individuals (donors; controls) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immuno analytical assayThe 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. | Diagnostic test | Malaria patients, Non malaria donors |
Primary outcome
MSP1-19 malaria antigen
Time frame: one year
Number of participants with MSP1-19 malaria antigen as assessed by a lateral flow test kit.
1 secondary outcome
Anti-MSP1-19 malaria antibody
Time frame: three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Individual participant dataSharing planned: Yes. Data will be deposited in Zenodo's open data repository service (CERN). Additionally, all datasets will be stored on external drives and in-house computers. The data will be deposited as soon as possible unless there is a legitimate reason and a decision has been agreed upon to protect the data. Before the upload of datasets, a unique DOI will be assigned, which will be stated in publications to direct readers to the primary datasets. Due to the public health interest of the outcome of this work, the datasets will be shared directly with relevant stakeholders for a wider public audience. There will be restricted datasets on the subject partaking in the study to protect their identity. This restriction will not affect the dissemination of the research outputs to the broader public. Although the datasets will be stored in the Zenodo repository for long-term preservation, the in-house datasets will be stored on an external drive for additional long-term benefit.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adjei study director
Shai-Osudoku District Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immuno analytical assay in people with Malaria, run by University of Ghana at 1 site in Ghana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MSP1-19 malaria antigen (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023.