Evaluating the Clinical Performance and Usability of Novel Malaria RDTs in Brazil

NCT ID: NCT05317117

Last Updated: 2022-09-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1030 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-04
• Study Completion Date: 2022-12-31

Brief Summary

Prospective cross-sectional diagnostic accuracy study with 1,000 patient participants and 30 lay provider/health care worker participants. The patient participant population will be recruited at clinics. At the point of care, study staff will collect capillary blood samples and conduct malaria microscopy (both the standard of care and study specific research-grade microscopy) and two index tests: the NxTek™ Malaria P.f plus Rapid Diagnostic Test (RDT) and the NxTek™ Malaria P.f/P.v RDT. Venous blood will be collected and transferred to the laboratory where the reference PCR assay and three comparator RDTs will be run. The index RDTs will also be repeated in the laboratory. All clinical management of study participants will follow the standard of care for malaria diagnosis in Brazil and will be based on the standard microscopy result. Confirmatory testing may also be conducted, such as typing and sequencing of Plasmodium genes and antigens of interest, including but not limited to HRP2, HRP3, and pLDH as well as the human inflammatory response marker CRP.

The lay provider/health worker participants will include intended users of the index tests. They will be surveyed to assess index test usability through a questionnaire to assess label and packaging comprehension as well as results interpretation.

Detailed Description

Primary Objectives

1.1 To assess the sensitivity, specificity and, when applicable, positive and negative predicting values (PPV and NPV) [altogether referred to hereafter as "diagnostic accuracy"] of NxTek™ Malaria Pf Plus in intended use settings for detecting P. falciparum infections in capillary whole blood samples collected prospectively from patients with symptoms suggestive of malaria.

1.2 To assess the diagnostic accuracy of NxTek™ Malaria Pf/Pv Plus in intended use settings for detecting P. falciparum and P. vivax infections in capillary whole blood samples collected prospectively from patients with symptoms suggestive of malaria.

Secondary Objectives

2.1 To assess the diagnostic accuracy of the study comparator tests in intended use settings for detecting P. falciparum and P. vivax infections in venous whole blood samples collected prospectively from patients with symptoms suggestive of malaria.

1.3 To determine the frequency of P. falciparum infections containing HRP2 and/or HRP3 mutations and assess the impact of those on HRP2-based RDT diagnostic accuracy.

1.4 To assess the comprehension of the test packaging and labeling among intended users (trained lay providers and trained health care workers).

1.5 To assess the ability to read and interpret the test result outputs among intended users (trained lay providers and trained health care workers).

Conditions

Malaria

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

NxTek™ Malaria P.f plus Rapid Diagnostic Test (RDT) and NxTek™ Malaria P.f/P.v RDT

All participants will be tested with two investigational IVDs at the point of care, the NxTek™ Malaria P.f plus Rapid Diagnostic Test (RDT) and the NxTek™ Malaria P.f/P.v RDT, in addition to comparator tests and the standard of care (microscopy). The investigational tests will not be used to determine any treatment or case management.

Group Type: OTHER

NxTek™ Malaria P.f plus Rapid Diagnostic Test (RDT) and NxTek™ Malaria P.f/P.v RDT

Intervention Type: DIAGNOSTIC_TEST

The NxTek (TM) Malaria Pf Plus, developed by Abbott, is a sensitive rapid chromatographic immunoassay for the qualitative detection of histidine-rich protein 2 (HRP2) and pLDH on a single test line of Pf malaria in human whole blood. This test is a lateral flow test for in vitro professional diagnostic use and intended as an aid to early diagnosis of Malaria infection in-patients with clinical symptoms.

The NxTek (TM) Malaria Pf/Pv Plus, developed by Abbott, is a sensitive rapid chromatographic immunoassay for the qualitative detection of histidine-rich protein 2 (HRP2) and Plasmodium lactate dehydrogenase (pLDH) of Plasmodium falciparum (Pf) on one test line and of pLDH of Plasmodium vivax (Pv) malaria on a second test line in human whole blood. This test is a lateral flow test for in vitro professional diagnostic use and intended as an aid to early diagnosis of Malaria infection in-patients with clinical symptoms.

Interventions

NxTek™ Malaria P.f plus Rapid Diagnostic Test (RDT) and NxTek™ Malaria P.f/P.v RDT

The NxTek (TM) Malaria Pf Plus, developed by Abbott, is a sensitive rapid chromatographic immunoassay for the qualitative detection of histidine-rich protein 2 (HRP2) and pLDH on a single test line of Pf malaria in human whole blood. This test is a lateral flow test for in vitro professional diagnostic use and intended as an aid to early diagnosis of Malaria infection in-patients with clinical symptoms.

The NxTek (TM) Malaria Pf/Pv Plus, developed by Abbott, is a sensitive rapid chromatographic immunoassay for the qualitative detection of histidine-rich protein 2 (HRP2) and Plasmodium lactate dehydrogenase (pLDH) of Plasmodium falciparum (Pf) on one test line and of pLDH of Plasmodium vivax (Pv) malaria on a second test line in human whole blood. This test is a lateral flow test for in vitro professional diagnostic use and intended as an aid to early diagnosis of Malaria infection in-patients with clinical symptoms.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Aged 2 years of age or older
• Presenting at the study site with fever or a history of fever during the preceding 48-hours
• Freely agreeing to participate by providing informed consent (and assent, as applicable)

• Aged 18 years of age or older
• Provides malaria case management at the study site
• Considered an intended user of the index tests (lay user or healthcare worker)
• Freely agreeing to participate by providing informed consent

Exclusion Criteria

• Presence of symptoms and signs of severe illness and/or central nervous system infections as defined by WHO guidelines

None

• Minimum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centro de Pesquisa em Medicina Tropical de Rondonia

OTHER_GOV

Sponsor Role: collaborator

PATH

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gonzalo Domingo, PhD

Role: PRINCIPAL_INVESTIGATOR

PATH

Locations

Centro de Pesquisa em Medicina Tropical de Rondônia (CEPEM)

Porto Velho, Rondônia, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Gonzalo Domingo, PhD

Role: CONTACT

gdomingo@path.org

(206) 285-3500

Stephanie Zobrist, MPH

Role: CONTACT

szobrist@path.org

(206) 285-3500

Facility Contacts

Dhélio Pereira, MD, PhD

Role: primary

Other Identifiers

1807405

Identifier Type: -

Identifier Source: org_study_id