MalariaAutoMicNCT04558515
Automated Microscopy Evaluation Study
An observational study of Malaria, run by Foundation for Innovative New Diagnostics, Switzerland at 1 site in Sudan.
Trial summary
Since the introduction of Giemsa stain in 1904 until today, malaria microscopy has been the standard of practice for malaria diagnosis. However, microscopic detection of malaria parasites is labour-intensive, time-consuming and expertise-demanding. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Malaria
- What is being tested?
- Novel malaria diagnostics & tools
- How many people
- 190 participants
- Where
- 1 siteSudan
- Study dates
- 1 Feb 2020to 31 Dec 2021
- Phase
- Observational
- 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with symptoms suggestive of malaria seeking clinical care in health facilities
Who may be able to join
- Aged 5 years or older
- Malaria status (positive or negative) established by microscopy at the health facility, where the patient is presenting
- Freely agreeing to participate by signing an informed consent form (adults aged 18 and older and parent/legal guardian of a child) and providing assent (children aged 13-17)
- Willing to provide finger prick blood sample at enrollment
Who cannot join
- Having received antimalarial treatment during the preceding four-week period
- Presence of symptoms and signs of severe disease and/or central nervous system infections, as defined by WHO guidelines
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Automated Microscope Solutions for Malaria Diagnosis
Since the introduction of Giemsa stain in 1904 until today, malaria microscopy has been the standard of practice for malaria diagnosis. However, microscopic detection of malaria parasites is labour-intensive, time-consuming and expertise-demanding. Moreover, the slide interpretation is highly dependent on the staining technique and the technician's expertise.
To address these, multiple organisations have developed next generation microscopes to move towards a next generation microscope that can improve slide preparation, interpretation or data collection, or a combination of these features.
In this study, a prospective evaluation of miLab™ and other next generation automated microscope solutions as well as a malaria rapid diagnostic test (RDT) reader app will be performed in malaria-endemic countries to assess their clinical performance for detection of malaria clinical cases at POC.
- Conditions
- Malaria
- Being tested
- Novel malaria diagnostics & tools
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel malaria diagnostics & toolsDiagnostic test
Next generation microscopy tools for malaria diagnosis and medical applications
| Study group | Role | What they receive |
|---|---|---|
| Case | Symptomatic patients positive for malaria by PCR Receives: Diagnostic Test: Novel malaria diagnostics & tools | |
| Control | Symptomatic patients negative for malaria by PCR Receives: Diagnostic Test: Novel malaria diagnostics & tools |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance assessment
Point estimates of clinical performance characteristics with 95% confidence intervals (sensitivity, specificity) of next generation microscopy tools using nPCR as the reference test for the detection of malaria clinical cases
Measured: up to 6 months
Concordance
Point estimate with 95% confidence intervals of the percentage agreement in interpreting malaria diagnostics between the app and visual reading
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start1 Feb 2020
- Primary completion1 Jul 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Innovative New Diagnostics, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04558515
- Sponsor's protocol ID
- MA013
- Acronym
- AutoMic
- Status last verified
- Nov 2023
- First submitted
- 15 Sep 2020
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hamid MMA, Mohamed AO, Mohammed FO, Elaagip A, Mustafa SA, Elfaki T, Jebreel WMA, Albsheer MM, Dittrich S, Owusu EDA, Yerlikaya S. Diagnostic accuracy of an automated microscope solution (miLab) in detecting malaria parasites in symptomatic patients at point-of-care in Sudan: a case-control study. Malar J. 2024 Jun 28;23(1):200. doi: 10.1186/s12936-024-05029-3.
PubMed 38943203
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Automated Microscope Solutions for Malaria Diagnosis
- ClinicalTrials.gov ID
- NCT04558515
- Acronym / sponsor ID
- AutoMic / MA013
- Conditions
- Malaria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Foundation for Innovative New Diagnostics, SwitzerlandUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 22 Sep 2020 (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.
Since the introduction of Giemsa stain in 1904 until today, malaria microscopy has been the standard of practice for malaria diagnosis. However, microscopic detection of malaria parasites is labour-intensive, time-consuming and expertise-demanding. Moreover, the slide interpretation is highly dependent on the staining technique and the technician's expertise.
To address these, multiple organisations have developed next generation microscopes to move towards a next generation microscope that can improve slide preparation, interpretation or data collection, or a combination of these features.
In this study, a prospective evaluation of miLab™ and other next generation automated microscope solutions as well as a malaria rapid diagnostic test (RDT) reader app will be performed in malaria-endemic countries to assess their clinical performance for detection of malaria clinical cases at POC.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Diagnostic Test: Novel malaria diagnostics & toolsSymptomatic patients positive for malaria by PCR |
| Control | – | Diagnostic Test: Novel malaria diagnostics & toolsSymptomatic patients negative for malaria by PCR |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with symptoms suggestive of malaria seeking clinical care in health facilities
Key inclusion criteria (4 listed)
- Aged 5 years or older
- Malaria status (positive or negative) established by microscopy at the health facility, where the patient is presenting
- Freely agreeing to participate by signing an informed consent form (adults aged 18 and older and parent/legal guardian of a child) and providing assent (children aged 13-17)
- Willing to provide finger prick blood sample at enrollment
Key exclusion criteria (2 listed)
- Having received antimalarial treatment during the preceding four-week period
- Presence of symptoms and signs of severe disease and/or central nervous system infections, as defined by WHO guidelines
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 |
|---|---|---|
| Novel malaria diagnostics & toolsNext generation microscopy tools for malaria diagnosis and medical applications | Diagnostic test | Case, Control |
Primary outcome
Clinical performance assessment
Time frame: up to 6 months
Point estimates of clinical performance characteristics with 95% confidence intervals (sensitivity, specificity) of next generation microscopy tools using nPCR as the reference test for the detection of malaria clinical cases
Concordance
Time frame: up to 6 months
Point estimate with 95% confidence intervals of the percentage agreement in interpreting malaria diagnostics between the app and visual reading
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Derived from this study: PubMed 38943203Hamid MMA, Mohamed AO, Mohammed FO, Elaagip A, Mustafa SA, Elfaki T, Jebreel WMA, Albsheer MM, Dittrich S, Owusu EDA, Yerlikaya S. Diagnostic accuracy of an automated microscope solution (miLab) in detecting malaria parasites in symptomatic patients at point-of-care in Sudan: a case-control study. Malar J. 2024 Jun 28;23(1):200. doi: 10.1186/s12936-024-05029-3.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malaria, run by Foundation for Innovative New Diagnostics, Switzerland at 1 site in Sudan.
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 4 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: finished, as of the sponsor's last update on 18 Nov 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 Sudan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical performance assessment (time frame: up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04558515, which also lists 1 linked publication.
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 18 Nov 2023.