MalariaNCT05317117
Evaluating the Clinical Performance and Usability of Novel Malaria RDTs in Brazil
A study testing NxTek™ Malaria P.f plus Rapid Diagnostic Test (RDT) and NxTek™ Malaria P.f/P.v RDT in people with Malaria, run by PATH at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- NxTek™ Malaria P.f plus Rapid Diagnostic Test (RDT) and NxTek™ Malaria P.f/P.v RDT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,030 participants
- Where
- 1 siteBrazil
- Study dates
- 4 Jul 2022to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Presence of symptoms and signs of severe illness and/or central nervous system infections as defined by WHO guidelines
- None
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Centro de Pesquisa em Medicina Tropical de Rondônia (CEPEM)
Porto Velho, Rondônia, 76812-329
Dhélio Pereira, MD, PhD
Dhélio Pereira, MD, PhD
About this study
Official title: Evaluating the Clinical Performance and Usability of Novel Malaria Rapid Diagnostic Tests (RDTs) for the Detection of Plasmodium Malaria Infections in Brazil
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.
Read the 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
- Being tested
- NxTek™ Malaria P.f plus Rapid Diagnostic Test (RDT) and NxTek™ Malaria P.f/P.v RDT
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NxTek™ Malaria P.f plus Rapid Diagnostic Test (RDT) and NxTek™ Malaria P.f/P.v RDTDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: NxTek™ Malaria P.f plus Rapid Diagnostic Test (RDT) and NxTek™ Malaria P.f/P.v RDT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 5 months
Secondary outcomes (5)
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.
Measured: 5 months
Frequency of P. falciparum infections containing HRP2 and/or HRP3 mutations.
2.2 Frequency of P. falciparum infections containing HRP2 and/or HRP3 mutations.
Measured: 5 months
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.
Measured: 5 months
Usability: label comprehension
2.4 Percent of end users who can accurately comprehend key messaging included in the investigational device packaging and labels.
Measured: 1 week
Usability: results interpretation
2.5 Percent of end users who can accurately interpret the investigational device result output.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start4 Jul 2022
- Primary completion1 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,030 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PATH
- Sponsor type
- University, hospital or other
- Collaborators
- Centro de Pesquisa em Medicina Tropical de Rondonia
- Responsible party
- Sponsor
- Investigators
- Gonzalo Domingo, PhD, Principal investigator, PATH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05317117
- Sponsor's protocol ID
- 1807405
- Status last verified
- Oct 2021
- First submitted
- 30 Mar 2022
- Last updated
- 27 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share any IPD with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Clinical Performance and Usability of Novel Malaria Rapid Diagnostic Tests (RDTs) for the Detection of Plasmodium Malaria Infections in Brazil
- ClinicalTrials.gov ID
- NCT05317117
- Acronym / sponsor ID
- 1807405
- Conditions
- Malaria
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,030 participants (estimated)
- Lead sponsor
- PATHUniversity, hospital or other
- Collaborators
- Centro de Pesquisa em Medicina Tropical de Rondonia
- Study start
- 4 Jul 2022 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 7 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NxTek™ Malaria P.f plus Rapid Diagnostic Test (RDT) and NxTek™ Malaria P.f/P.v RDT | Other | Diagnostic Test: NxTek™ Malaria P.f plus Rapid Diagnostic Test (RDT) and NxTek™ Malaria P.f/P.v RDTAll 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. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Presence of symptoms and signs of severe illness and/or central nervous system infections as defined by WHO guidelines
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NxTek™ Malaria P.f plus Rapid Diagnostic Test (RDT) and NxTek™ Malaria P.f/P.v RDTThe 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. | Diagnostic test | NxTek™ Malaria P.f plus Rapid Diagnostic Test (RDT) and NxTek™ Malaria P.f/P.v RDT |
Primary outcome
Diagnostic accuracy of NxTek™ Malaria Pf Plus for the detection of P. falciparum infections
Time frame: 5 months
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.
Diagnostic accuracy of of NxTek™ Malaria Pf/Pv Plus for the detection of P. falciparum and P.vivax infections
Time frame: 5 months
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 secondary outcomes
Diagnostic accuracy of comparator tests for the detection of P. falciparum and, when relevant, P.vivax infections
Time frame: 5 months
Frequency of P. falciparum infections containing HRP2 and/or HRP3 mutations.
Time frame: 5 months
Diagnostic accuracy of the index tests for the detection of P. falciparum infections with HRP2 and/or HRP3 deletions
Time frame: 5 months
Usability: label comprehension
Time frame: 1 week
Usability: results interpretation
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
- Individual participant dataSharing planned: No. There is no plan to share any IPD with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gonzalo Domingo, PhD principal investigator
PATH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NxTek™ Malaria P.f plus Rapid Diagnostic Test (RDT) and NxTek™ Malaria P.f/P.v RDT in people with Malaria, run by PATH at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gonzalo Domingo, PhD ((206) 285-3500, gdomingo@path.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of NxTek™ Malaria Pf Plus for the detection of P. falciparum infections (time frame: 5 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2022.