Clinical trial NCT06225700: Clinical Validation of Novel Malaria Diagnostic Tools for POC Point-of-Care Testing
Official title: Clinical Validation of Novel Malaria Diagnostic Tools for Point-of-Care Testing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malaria
Diagnoses Disease
RDT
Keywords: Malaria, diagnostics
Lead sponsor: Foundation for Innovative New Diagnostics, Switzerland
Sponsor class: OTHER
Collaborators: name: Australian Government
First posted: 2024-01-26
Enrollment: 509
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Performance of nPOC
timeFrame: 3 months
Secondary outcomes:
measure: Performance of LM
timeFrame: 3 months
measure: Performance of comparator RDT
timeFrame: 3 months
measure: Comparison between nPOC [Truenat® Malaria Pv/Pf; Truenat® Malaria Pv/Pf Hi-Sens; Humasis Hs-Malaria P.f/Pan test, Hemozoin Imager] and LM
timeFrame: 3 months
measure: Comparison between Hemozoin Imager and comparator RDT
timeFrame: 3 months
measure: Comparison of Truenat Pv/Pf and Truenat Pv/Pf High-Sens
timeFrame: 3 months
measure: Comparison between Truenat Pv/Pf and Truenat Pv/Pf High-Sens and Realstar
timeFrame: 3 months
measure: Foot odour collection
timeFrame: 3 months
Other outcomes:
Locations:
city: Kigali
country: Rwanda
facility: Stansile
Study officials:
References:
citation: World Health Organization. "False-Negative RDT Results and P. Falciparum Histidine-Rich Protein 2/3 Gene Deletions." Global Malaria Programme, July 2019.
citation: World Health Organization, 2018. Malaria Rapid Diagnostic Test Performance; Summary results of WHO product testing of malaria RDTs: round 1-8 (2008-2018). Geneva.
citation: World Health Organization, 2015. Control and Elimination of Plasmodium Vivax Malaria: A Technical Brief. Geneva: WHO Press.