MalariaNCT06225700
Clinical Validation of Novel Malaria Diagnostic Tools for POC Point-of-Care Testing
An observational study of Malaria and Diagnoses Disease, run by Foundation for Innovative New Diagnostics, Switzerland at 1 site in Rwanda.
Trial summary
The aim of this study is to perform a performance evaluation of novel diagnostic tools for detecting malaria in malaria-endemic countries. At the beginning of 2022, FIND launched a call for innovation with the distinct aim to identify malaria innovations that have the potential to address the technical and operational… Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Malaria, Diagnoses Disease, RDT
- How many people
- 509 participants
- Where
- 1 siteRwanda
- Study dates
- 1 Mar 2023to 1 Aug 2023
- 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: The study will be conducted in multiple primary health care facilities (e.g., health posts, health centres) where malaria diagnosis is provided on a routine basis in malaria-endemic Rwanda. The study population will be patients with symptoms suggestive of malaria seeking clinical care in a health facility.
Who may be able to join
- Aged 5 years or older
- Presenting at the study site with symptoms and signs suggestive of malaria
- 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 venous blood sample and other samples such as foot odour.
Who cannot join
- Presence of symptoms and signs of severe disease and/or central nervous system infections, as defined by WHO guidelines
- Participants are excluded from the foot odour collection if the following exclusion criteria apply:
- Skin lesions on the feet
- Infected skin on the feet
- Infected toenails
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Validation of Novel Malaria Diagnostic Tools for Point-of-Care Testing
The aim of this study is to perform a performance evaluation of novel diagnostic tools for detecting malaria in malaria-endemic countries. At the beginning of 2022, FIND launched a call for innovation with the distinct aim to identify malaria innovations that have the potential to address the technical and operational limitations of current malaria RDTs, particularly in view of the emergence of P. falciparum parasites with hrp2/3 deletions, the need for improved tools to identify all Plasmodium species and/or the need for improved surveillance.
This study will generate valuable data on the performance of these novel non-HRP2-based tests and inform FIND and developers on technical and operational assay optimization requirements for accelerated access of these tools to market.
Read the detailed description
This study aims to support product development efforts towards novel malaria diagnostics not HRP2-based by providing early-stage technology developers with valuable information on performance and basic feasibility data that can help to accelerate development. The WHO now recommends that where pfhrp2/3 gene deletions are reported (within countries or in neighboring countries), representative baseline surveys are to be conducted among suspected cases. If >5% of false negative RDT results are attributed to these deletions, a change in RDT is necessary. Plasmodium lactate dehydrogenase (pLDH), appears as a good alternative to HRP2 as it is an essential protein expressed by all human-infecting Plasmodium species. However, pLDH-based RDTs have shown to perform poorly at low parasitaemia, which is common among patients infected with P. vivax, P. malariae and P. ovale species as well as in asymptomatic infections. Thus, RDTs not based on HRP2 are limited; moreover, WHO prequalified ones that can detect and distinguish between Plasmodium falciparum and Plasmodium vivax are non-existent. The current malaria diagnostic landscape demands more innovation supporting and accelerating the development of new malaria diagnostic tools that that tackle these emerging issues.
- Conditions
- Malaria, Diagnoses Disease, RDT
- Keywords
- Malaria, diagnostics
- Medical subject headings
- Malaria
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of nPOC
Point estimates of clinical performance characteristics (sensitivity, specificity, NPV, PPV, and DOR) with 95% confidence intervals of nPOC using nPCR as reference for detecting malaria in patients with symptoms suggestive of malaria.
Measured: 3 months
Secondary outcomes (7)
Performance of LM
Point estimates of clinical performance characteristics with 95% confidence intervals (sensitivity, specificity, NPV, PPV, and DOR) of light microscopy using nPCR as reference for detecting malaria in patients with symptoms suggestive of malaria
Measured: 3 months
Performance of comparator RDT
Point estimates of clinical performance characteristics with 95% confidence intervals (sensitivity, specificity, NPV, PPV, and DOR) of the comparator tests using nPCR as reference for detecting malaria in patients with symptoms suggestive of malaria
Measured: 3 months
Comparison between nPOC [Truenat® Malaria Pv/Pf; Truenat® Malaria Pv/Pf Hi-Sens; Humasis Hs-Malaria P.f/Pan test, Hemozoin Imager] and LM
Comparison between the clinical performance of nPOC and light microscopy
Measured: 3 months
Comparison between Hemozoin Imager and comparator RDT
Comparison between the clinical performance of between the clinical performance of Hemozoin Imager and comparator rapid diagnostic test [SD Bioline Combo/ First Response].
The percentage difference between the clinical performance characteristics of nPOC and comparator RDT with 95% confidence intervals using Tango's score method.
Measured: 3 months
Comparison of Truenat Pv/Pf and Truenat Pv/Pf High-Sens
Comparison between clinical performance of Truenat® Pv/Pf and Truenat® Pv/Pf Hi-Sens.
The percentage difference between the clinical performance characteristics of Truenat® Pv/Pf and Truenat® Pv/Pf Hi-Sens with 95% confidence intervals using Tango's score method.
Measured: 3 months
Comparison between Truenat Pv/Pf and Truenat Pv/Pf High-Sens and Realstar
Comparison between the clinical performance of Truenat® Pv/Pf and Truenat® Pv/Pf Hi-Sens with that of RealStar® Malaria Screen \& Type PCR Kit 1.0.
The percentage difference between the clinical performance characteristics of the Truenat® tests (Truenat® Pv/Pf and Truenat® Pv/Pf Hi-Sens) and RealStar® Malaria Screen \& Type PCR Kit 1.0 with 95% confidence intervals using Tango's score method.
Measured: 3 months
Foot odour collection
The number of volatile organic compound (foot odour samples) from Plasmodium positive and negative febrile patients that have been collected.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start1 Mar 2023
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 only
- Time perspective
- Prospective
- Enrolment
- 509 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Innovative New Diagnostics, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Australian Government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06225700
- Sponsor's protocol ID
- MA017
- Status last verified
- Mar 2023
- First submitted
- 23 Jan 2023
- Last updated
- 26 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
World Health Organization. "False-Negative RDT Results and P. Falciparum Histidine-Rich Protein 2/3 Gene Deletions." Global Malaria Programme, July 2019.
World Health Organization, 2018. Malaria Rapid Diagnostic Test Performance; Summary results of WHO product testing of malaria RDTs: round 1-8 (2008-2018). Geneva.
World Health Organization, 2015. Control and Elimination of Plasmodium Vivax Malaria: A Technical Brief. Geneva: WHO Press.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of Novel Malaria Diagnostic Tools for Point-of-Care Testing
- ClinicalTrials.gov ID
- NCT06225700
- Acronym / sponsor ID
- MA017
- Conditions
- Malaria, Diagnoses Disease, RDT
- Keywords
- Malaria, diagnostics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 509 participants (actual)
- Lead sponsor
- Foundation for Innovative New Diagnostics, SwitzerlandUniversity, hospital or other
- Collaborators
- Australian Government
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 26 Jan 2024 (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.
The aim of this study is to perform a performance evaluation of novel diagnostic tools for detecting malaria in malaria-endemic countries. At the beginning of 2022, FIND launched a call for innovation with the distinct aim to identify malaria innovations that have the potential to address the technical and operational limitations of current malaria RDTs, particularly in view of the emergence of P. falciparum parasites with hrp2/3 deletions, the need for improved tools to identify all Plasmodium species and/or the need for improved surveillance.
This study will generate valuable data on the performance of these novel non-HRP2-based tests and inform FIND and developers on technical and operational assay optimization requirements for accelerated access of these tools to market.
Detailed description
This study aims to support product development efforts towards novel malaria diagnostics not HRP2-based by providing early-stage technology developers with valuable information on performance and basic feasibility data that can help to accelerate development. The WHO now recommends that where pfhrp2/3 gene deletions are reported (within countries or in neighboring countries), representative baseline surveys are to be conducted among suspected cases. If >5% of false negative RDT results are attributed to these deletions, a change in RDT is necessary. Plasmodium lactate dehydrogenase (pLDH), appears as a good alternative to HRP2 as it is an essential protein expressed by all human-infecting Plasmodium species. However, pLDH-based RDTs have shown to perform poorly at low parasitaemia, which is common among patients infected with P. vivax, P. malariae and P. ovale species as well as in asymptomatic infections. Thus, RDTs not based on HRP2 are limited; moreover, WHO prequalified ones that can detect and distinguish between Plasmodium falciparum and Plasmodium vivax are non-existent. The current malaria diagnostic landscape demands more innovation supporting and accelerating the development of new malaria diagnostic tools that that tackle these emerging issues.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will be conducted in multiple primary health care facilities (e.g., health posts, health centres) where malaria diagnosis is provided on a routine basis in malaria-endemic Rwanda. The study population will be patients with symptoms suggestive of malaria seeking clinical care in a health facility.
Key inclusion criteria (4 listed)
- Aged 5 years or older
- Presenting at the study site with symptoms and signs suggestive of malaria
- 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 venous blood sample and other samples such as foot odour.
Key exclusion criteria (5 listed)
- Presence of symptoms and signs of severe disease and/or central nervous system infections, as defined by WHO guidelines
- Participants are excluded from the foot odour collection if the following exclusion criteria apply:
- Skin lesions on the feet
- Infected skin on the feet
- Infected toenails
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Performance of nPOC
Time frame: 3 months
Point estimates of clinical performance characteristics (sensitivity, specificity, NPV, PPV, and DOR) with 95% confidence intervals of nPOC using nPCR as reference for detecting malaria in patients with symptoms suggestive of malaria.
7 secondary outcomes
Performance of LM
Time frame: 3 months
Performance of comparator RDT
Time frame: 3 months
Comparison between nPOC [Truenat® Malaria Pv/Pf; Truenat® Malaria Pv/Pf Hi-Sens; Humasis Hs-Malaria P.f/Pan test, Hemozoin Imager] and LM
Time frame: 3 months
Comparison between Hemozoin Imager and comparator RDT
Time frame: 3 months
Comparison of Truenat Pv/Pf and Truenat Pv/Pf High-Sens
Time frame: 3 months
Comparison between Truenat Pv/Pf and Truenat Pv/Pf High-Sens and Realstar
Time frame: 3 months
Foot odour collection
Time frame: 3 months
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 26 Jan 2024.
- BackgroundWorld Health Organization. "False-Negative RDT Results and P. Falciparum Histidine-Rich Protein 2/3 Gene Deletions." Global Malaria Programme, July 2019.
- BackgroundWorld Health Organization, 2018. Malaria Rapid Diagnostic Test Performance; Summary results of WHO product testing of malaria RDTs: round 1-8 (2008-2018). Geneva.
- BackgroundWorld Health Organization, 2015. Control and Elimination of Plasmodium Vivax Malaria: A Technical Brief. Geneva: WHO Press.
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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 and Diagnoses Disease, run by Foundation for Innovative New Diagnostics, Switzerland at 1 site in Rwanda.
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 5 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 26 Jan 2024. 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 Rwanda. 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?
Performance of nPOC (time frame: 3 months). 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 NCT06225700, which also lists 3 linked publications.
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 26 Jan 2024.