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Performance Evaluation of Malaria Plus RDTs

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ClinicalTrials.gov Identifier: NCT03960632
Recruitment Status : Not yet recruiting
First Posted : May 23, 2019
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
Foundation for Innovative New Diagnostics, Switzerland

Study Description
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Brief Summary:

Since their introduction in the late 90's, rapid diagnostic tests (RDTs) have dramatically improved our ability to control malaria, but proved insufficient to support elimination efforts because of their limited sensitivity, especially for P. vivax. In addition, the spread of P. falciparum parasites lacking hrp2 gene jeopardizes the long-term use of P. falciparum-specific HRP2-based RDTs. An existing partnership between Standard Diagnostics (SD), FIND, PATH, and Bill and Melinda Gates Foundation (BMGF) is addressing these limitations by developing two novel malaria RDTs with an analytical sensitivity ten times higher than the currently available malaria RDTs: a P. falciparum-specific test targeting both the HRP2 and PfLDH antigens (Pf Plus), and a P. falciparum/P. vivax combo test additionally targeting the PvLDH antigen (Pf/Pv Plus).

These new combo tests with improved sensitivity may become promising diagnostic tools for the detection of malaria, especially in settings where current tests prove to be insufficient due to hrp2 deletion or high burden of P. vivax malaria.

In this study, the investigators will perform a prospective evaluation of Pf Plus and Pf/Pv Plus tests in malaria-endemic countries to assess their clinical performance for detection of malaria in their intended-use settings.


Condition or disease Intervention/treatment
Malaria Diagnostic Test: Abbott SD Bioline Malaria Pf Plus (05FK150) and Abbott SD Bioline Malaria Pf/Pv Plus (05FK160))

Study Design
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Study Type : Observational
Estimated Enrollment : 6546 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Clinical Performance Evaluation of Malaria Pf Plus RDT and Malaria Pf/Pv Plus RDT for the Detection of Plasmodium Infections in Patients With Symptoms Suggestive of Malaria
Estimated Study Start Date : June 2021
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: Abbott SD Bioline Malaria Pf Plus (05FK150) and Abbott SD Bioline Malaria Pf/Pv Plus (05FK160))
    Qualitative in vitro tests for the detection of Plasmodium antigens

Outcome Measures
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Primary Outcome Measures :
  1. Estimates of clinical performance characteristics of Pf Plus [ Time Frame: Enrolment ]
    Estimates of clinical performance characteristics with 95% confidence intervals (sensitivity, specificity, NPV, PPV, and DOR) of Pf Plus using the primary reference test (qPCR) as standard of truth for the detection of malaria in patients with symptoms suggestive of malaria

  2. Estimates of clinical performance characteristics of Pf/Pv Plus [ Time Frame: Enrolment ]
    Estimates of clinical performance characteristics with 95% confidence intervals (sensitivity, specificity, NPV, PPV, and DOR) of Pf/Pv Plus using the primary reference test (qPCR) as standard of truth for the detection of malaria in patients with symptoms suggestive of malaria


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with symptoms suggestive of malaria seeking clinical care in health facilities
Criteria

Inclusion Criteria:

  • Presenting at the study site with fever (axillary temperature ≥37.5°C) or a history of fever during the preceding 72 hours period
  • Presence of symptoms and signs other than fever suggestive of malaria
  • Aged 5 years or older
  • 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 enrolment

Exclusion Criteria:

  • Presence of symptoms and signs of severe disease and/or central nervous system infections, as defined by WHO guidelines
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Foundation for Innovative New Diagnostics, Switzerland
ClinicalTrials.gov Identifier: NCT03960632    
Other Study ID Numbers: 7874-2/1
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases
Infections
Vector Borne Diseases