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

NCT05317117 | Unknown

• 1 other identifier: 1807405
• Study Type: interventional
• Target: 1,030
• Locations: 1 country
• Sites: 1

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.

Conditions

Malaria

Outcome Measures

Primary Outcomes (2)

• Diagnostic accuracy of NxTek™ Malaria Pf Plus for the detection of P. falciparum infections

  1.1 Estimates of diagnostic accuracy characteristics with 95% confidence intervals (sensitivity, specificity, NPV, PPV) of NxTek™ Malaria Pf Plus for the detection of P. falciparum infections in patients with symptoms suggestive of malaria.

  5 months

• Diagnostic accuracy of of NxTek™ Malaria Pf/Pv Plus for the detection of P. falciparum and P.vivax infections

  1.2 Estimates of diagnostic accuracy characteristics with 95% confidence intervals (sensitivity, specificity, NPV, PPV) of NxTek™ Malaria Pf/Pv Plus for the detection of P. falciparum and P.vivax infections in patients with symptoms suggestive of malaria.

  5 months

Secondary Outcomes (5)

• Diagnostic accuracy of comparator tests for the detection of P. falciparum and, when relevant, P.vivax infections

  5 months

• Frequency of P. falciparum infections containing HRP2 and/or HRP3 mutations.

  5 months

• Diagnostic accuracy of the index tests for the detection of P. falciparum infections with HRP2 and/or HRP3 deletions

  5 months

• Usability: label comprehension

  1 week

• Usability: results interpretation

  1 week

Study Arms (1)

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

OTHER

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.

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

Interventions

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

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

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• \- Presence of symptoms and signs of severe illness and/or central nervous system infections as defined by WHO guidelines
• 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
• None

Sponsors & Collaborators

• PATH: lead
• Centro de Pesquisa em Medicina Tropical de Rondonia: collaborator

Study Sites (1)

Centro de Pesquisa em Medicina Tropical de Rondônia (CEPEM)

Porto Velho, Rondônia, 76812-329, Brazil

RECRUITING

MeSH Terms

Conditions

Malaria

Interventions

Rapid Diagnostic Tests

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Point-of-Care Testing; Point-of-Care Systems; Patient Care Management; Health Services Administration

Study Officials

• Gonzalo Domingo, PhD

  PATH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gonzalo Domingo, PhD

CONTACT

(206) 285-3500; gdomingo@path.org

Stephanie Zobrist, MPH

CONTACT

(206) 285-3500; szobrist@path.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: April 7, 2022
• Study Start: July 4, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 31, 2022
• Last Updated: September 27, 2022

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)