NCT06225700

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
509

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
6 months until next milestone

First Posted

Study publicly available on registry

January 26, 2024

Completed
Last Updated

January 26, 2024

Status Verified

March 1, 2023

Enrollment Period

5 months

First QC Date

January 23, 2023

Last Update Submit

January 25, 2024

Conditions

MalariaDiagnoses DiseaseRDT

Keywords

Malaria, diagnostics

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Secondary Outcomes (7)

  • Performance of LM

    3 months

  • Performance of comparator RDT

    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

    3 months

  • Comparison between Hemozoin Imager and comparator RDT

    3 months

  • Comparison of Truenat Pv/Pf and Truenat Pv/Pf High-Sens

    3 months

  • +2 more secondary outcomes

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Presence of symptoms and signs of severe disease and/or central nervous system infections, as defined by WHO guidelines
  • Skin lesions on the feet
  • Infected skin on the feet
  • Infected toenails

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stansile

Kigali, KG622, Rwanda

Location

Related Publications (3)

  • World Health Organization. "False-Negative RDT Results and P. Falciparum Histidine-Rich Protein 2/3 Gene Deletions." Global Malaria Programme, July 2019.

    BACKGROUND

  • World Health Organization, 2018. Malaria Rapid Diagnostic Test Performance; Summary results of WHO product testing of malaria RDTs: round 1-8 (2008-2018). Geneva.

    BACKGROUND

  • World Health Organization, 2015. Control and Elimination of Plasmodium Vivax Malaria: A Technical Brief. Geneva: WHO Press.

    BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Capillary blood, Venous blood, Foot odour

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2023

First Posted

January 26, 2024

Study Start

March 1, 2023

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

January 26, 2024

Record last verified: 2023-03

Locations

RW(1)