Malaria Clinical Trial
Official title:
Evaluating the Clinical Performance and Usability of Novel Malaria Rapid Diagnostic Tests (RDTs) for the Detection of Plasmodium Malaria Infections in Brazil
NCT number | NCT05317117 |
Other study ID # | 1807405 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 4, 2022 |
Est. completion date | December 31, 2022 |
Verified date | October 2021 |
Source | PATH |
Contact | Gonzalo Domingo, PhD |
Phone | (206) 285-3500 |
gdomingo[@]path.org | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 1030 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 2 Years and older |
Eligibility | Inclusion Criteria (diagnostic accuracy): - 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) Exclusion Criteria (diagnostic accuracy): - Presence of symptoms and signs of severe illness and/or central nervous system infections as defined by WHO guidelines Inclusion Criteria (usability): - 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 (usability): None |
Country | Name | City | State |
---|---|---|---|
Brazil | Centro de Pesquisa em Medicina Tropical de Rondônia (CEPEM) | Porto Velho | Rondônia |
Lead Sponsor | Collaborator |
---|---|
PATH | Centro de Pesquisa em Medicina Tropical de Rondonia |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Diagnostic accuracy of comparator tests for the detection of P. falciparum and, when relevant, P.vivax infections | 2.1 Estimates of diagnostic accuracy characteristics with 95% confidence intervals (sensitivity, specificity, NPV, PPV) of comparator tests for the detection of P. falciparum and, when relevant, P.vivax infections in patients with symptoms suggestive of malaria. | 5 months | |
Secondary | Frequency of P. falciparum infections containing HRP2 and/or HRP3 mutations. | 2.2 Frequency of P. falciparum infections containing HRP2 and/or HRP3 mutations. | 5 months | |
Secondary | Diagnostic accuracy of the index tests for the detection of P. falciparum infections with HRP2 and/or HRP3 deletions | 2.3 Estimates of diagnostic accuracy characteristics with 95% confidence intervals (sensitivity, specificity, NPV, PPV) of the index tests for the detection of P. falciparum infections with HRP2 and/or HRP3 deletions in patients with symptoms suggestive of malaria. | 5 months | |
Secondary | Usability: label comprehension | 2.4 Percent of end users who can accurately comprehend key messaging included in the investigational device packaging and labels. | 1 week | |
Secondary | Usability: results interpretation | 2.5 Percent of end users who can accurately interpret the investigational device result output. | 1 week |
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