MalariaNCT05286359
Performance Evaluation of Malaria Plus Rapid Diagnostic Tests (RDTs) for the Detection of Plasmodium Infections in Patients With Symptoms Suggestive of Malaria
A study testing NxTekTM Malaria Pf Plus Rapid Diagnostic Test Device in people with Malaria, run by Abbott Rapid Dx at 1 site in Ethiopia.
Trial summary
This trial is part of a portfolio of studies designed to assess the clinical and operational performance of Abbott's NxTekTM Malaria Pf Plus and NxTekTM Malaria Pf/Pv Plus Rapid Test Devices. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Malaria
- What is being tested?
- NxTekTM Malaria Pf Plus Rapid Diagnostic Test Device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,023 participants
- Where
- 1 siteEthiopia
- Study dates
- 24 May 2022to 17 Nov 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Aged 5years old or older
- Presenting at the trial site with fever or a history of fever (axillary temp ≥ 37.5C) during the preceding 48hours
- Freely agreeing to participate by providing informed consent (and assent, if applicable)
Who cannot join
- Presence of symptoms and signs of severe illness and/or central nervous system infections as defined by WHO guidelines.
Trial locations and contacts
1 site in 1 country.
Ethiopia1 site
Medical Parasitology Research Unit, Aklilu Lemma Institute of Pathobiology (ALIPB), Addis Ababa University (AAU).
Addis Ababa
About this study
Official title: Multi-site, Prospective, Clinical Performance Evaluation of NxTekTM Malaria Pf Plus Rapid Diagnostic Test Device and NxTekTM Malaria Pf/Pv Plus Rapid Diagnostic Test (RDT) Device for the Detection of Plasmodium Infections in Patients With Symptoms Suggestive of Malaria
This trial is part of a portfolio of studies designed to assess the clinical and operational performance of Abbott's NxTekTM Malaria Pf Plus and NxTekTM Malaria Pf/Pv Plus Rapid Test Devices.
Read the detailed description
A prospective cross-sectional multi-center diagnostic accuracy trial in intended-use settings of the:
- NxTekTM Malaria Pf/Pv Plus Rapid Test Device for the qualitative detection histidine-rich protein II (HRP-II antigens) and pLDH of Plasmodium falciparum (P.f) and Plasmodium vivax (P.v) malaria in human whole blood.
- NxTekTM Malaria Pf PlusRapid Test Device for the qualitative detection of histidine-rich protein II (HRP-II antigens) and pLDH of Plasmodium falciparum (P.f) malaria in human whole blood.
- Conditions
- Malaria
- Being tested
- NxTekTM Malaria Pf Plus Rapid Diagnostic Test Device
- Keywords
- Plasmodium infection, Plasmodium falciparum, Plasmodium vivax
- Medical subject headings
- Malaria, Malaria, Falciparum, Malaria, Vivax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NxTekTM Malaria Pf Plus Rapid Diagnostic Test DeviceDiagnostic test
Also called NxTekTM Malaria Pf/Pv Plus Rapid Diagnostic Test Device
NxTekTM Malaria Pf/Pv Plus: A sensitive rapid chromatographic immunoassay for the qualitative detection of histidine-rich protein 2 (HRP2) and Plasmodium lactate dehydrogenase (pLDH) of Plasmodium falciparum(P.f.) on one test line and of pLDH of Plasmodium vivax (P.v.) 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.
NxTekTM Malaria Pf Plus: A sensitive rapid chromatographic immunoassay for the qualitative detection of histidine-rich protein 2 (HRP2) and pLDH on a single test line of Plasmodium falciparum(P.f.) 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.
| Study group | Role | What they receive |
|---|---|---|
| NxTekTM Malaria Plus Rapid Diagnostic Test (RDT) Devices | Experimental | Not described Receives: Diagnostic Test: NxTekTM Malaria Pf Plus Rapid Diagnostic Test Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the sensitivity, specificity, positive and negative predicting values (PPV and NPV) [altogether referred to hereafter as "diagnostic accuracy"] of NxTekTM Malaria Pf Plus
To assess the sensitivity, specificity, positive and negative predicting values (PPV and NPV) [altogether referred to hereafter as "diagnostic accuracy"] of NxTekTM Malaria Pf Plus in intended use settings for detecting P.f. infections in capillary whole blood samples collected prospectively from patients with symptoms suggestive of malaria (e.g. febrile).
Measured: 6 months
To assess the diagnostic accuracy of NxTekTM Malaria Pf/Pv Plus.
To assess the diagnostic accuracy of NxTekTM Malaria Pf/Pv Plus in intended use settings for detecting P.f. and P.v. infections in capillary whole blood samples collected prospectively from patients with symptoms suggestive of malaria (e.g. febrile).
Measured: 6 months
Secondary outcomes (2)
Estimates of diagnostic accuracy characteristics with 95% confidence intervals of comparator tests (05FK50, 05FK80, 05FK120, LM)
Estimates of diagnostic accuracy characteristics with 95% confidence intervals of comparator tests (05FK50, 05FK80, 05FK120, LM), using the reference test as standard of truth for the detection of P. falciparum and, when relevant, P.v. infections in patients with symptoms suggestive of malaria
Measured: 6 months
Estimates of diagnostic accuracy characteristics with 95% confidence intervals ofthe index tests for the detection of P.f.infections with hrp2 and/or hrp3 deletions
Estimates of diagnostic accuracy characteristics with 95% confidence intervals of the index tests for the detection of P.f. infections with hrp2 and/or hrp3 deletions in patients with symptoms suggestive of malaria
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start24 May 2022
- Primary completion17 Nov 2022
- Study completion17 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 1,023 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Rapid Dx
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
- Investigators
- Dr. Lemu Golassa, PhD, Principal investigator, Addis Ababa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05286359
- Sponsor's protocol ID
- SDRD-G-001-P
- Status last verified
- Apr 2023
- First submitted
- 9 Mar 2022
- Last updated
- 24 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mandefro A, Ding XC, Farge J, Alemayehu GS, Tadele G, Mekonen B, Gebrehiwot Y, Berhe N, Erko B, Slater HC, Bizilj GT, Barney R, Golden A, Domingo GJ, Golassa L. Performance of a Novel Plasmodium falciparum Rapid Diagnostic Test in Areas of Widespread hrp2/3 Gene Deletion. Clin Infect Dis. 2026 Feb 4;81(6):e491-e501. doi: 10.1093/cid/ciaf212.
PubMed 40274531
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-site, Prospective, Clinical Performance Evaluation of NxTekTM Malaria Pf Plus Rapid Diagnostic Test Device and NxTekTM Malaria Pf/Pv Plus Rapid Diagnostic Test (RDT) Device for the Detection of Plasmodium Infections in Patients With Symptoms Suggestive of Malaria
- ClinicalTrials.gov ID
- NCT05286359
- Acronym / sponsor ID
- SDRD-G-001-P
- Conditions
- Malaria
- Keywords
- Plasmodium infection, Plasmodium falciparum, Plasmodium vivax
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,023 participants (actual)
- Lead sponsor
- Abbott Rapid DxIndustry (pharma, biotech, devices)
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- 24 May 2022 (actual)
- Primary completion
- 17 Nov 2022 (actual)
- Study completion
- 17 Nov 2022 (actual)
- First posted
- 18 Mar 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.
This trial is part of a portfolio of studies designed to assess the clinical and operational performance of Abbott's NxTekTM Malaria Pf Plus and NxTekTM Malaria Pf/Pv Plus Rapid Test Devices.
Detailed description
A prospective cross-sectional multi-center diagnostic accuracy trial in intended-use settings of the:
- NxTekTM Malaria Pf/Pv Plus Rapid Test Device for the qualitative detection histidine-rich protein II (HRP-II antigens) and pLDH of Plasmodium falciparum (P.f) and Plasmodium vivax (P.v) malaria in human whole blood.
- NxTekTM Malaria Pf PlusRapid Test Device for the qualitative detection of histidine-rich protein II (HRP-II antigens) and pLDH of Plasmodium falciparum (P.f) malaria in human whole blood.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NxTekTM Malaria Plus Rapid Diagnostic Test (RDT) Devices | Experimental | Diagnostic Test: NxTekTM Malaria Pf Plus Rapid Diagnostic Test Device |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 5years old or older
- Presenting at the trial site with fever or a history of fever (axillary temp ≥ 37.5C) during the preceding 48hours
- Freely agreeing to participate by providing informed consent (and assent, if applicable)
Key exclusion criteria (1 listed)
- Presence of symptoms and signs of severe illness and/or central nervous system infections as defined by WHO guidelines.
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 |
|---|---|---|
| NxTekTM Malaria Pf Plus Rapid Diagnostic Test DeviceAlso: NxTekTM Malaria Pf/Pv Plus Rapid Diagnostic Test DeviceNxTekTM Malaria Pf/Pv Plus: A sensitive rapid chromatographic immunoassay for the qualitative detection of histidine-rich protein 2 (HRP2) and Plasmodium lactate dehydrogenase (pLDH) of Plasmodium falciparum(P.f.) on one test line and of pLDH of Plasmodium vivax (P.v.) 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. NxTekTM Malaria Pf Plus: A sensitive rapid chromatographic immunoassay for the qualitative detection of histidine-rich protein 2 (HRP2) and pLDH on a single test line of Plasmodium falciparum(P.f.) 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. | Diagnostic test | NxTekTM Malaria Plus Rapid Diagnostic Test (RDT) Devices |
Primary outcome
Assess the sensitivity, specificity, positive and negative predicting values (PPV and NPV) [altogether referred to hereafter as "diagnostic accuracy"] of NxTekTM Malaria Pf Plus
Time frame: 6 months
To assess the sensitivity, specificity, positive and negative predicting values (PPV and NPV) [altogether referred to hereafter as "diagnostic accuracy"] of NxTekTM Malaria Pf Plus in intended use settings for detecting P.f. infections in capillary whole blood samples collected prospectively from patients with symptoms suggestive of malaria (e.g. febrile).
To assess the diagnostic accuracy of NxTekTM Malaria Pf/Pv Plus.
Time frame: 6 months
To assess the diagnostic accuracy of NxTekTM Malaria Pf/Pv Plus in intended use settings for detecting P.f. and P.v. infections in capillary whole blood samples collected prospectively from patients with symptoms suggestive of malaria (e.g. febrile).
2 secondary outcomes
Estimates of diagnostic accuracy characteristics with 95% confidence intervals of comparator tests (05FK50, 05FK80, 05FK120, LM)
Time frame: 6 months
Estimates of diagnostic accuracy characteristics with 95% confidence intervals ofthe index tests for the detection of P.f.infections with hrp2 and/or hrp3 deletions
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
- Derived from this study: PubMed 40274531Mandefro A, Ding XC, Farge J, Alemayehu GS, Tadele G, Mekonen B, Gebrehiwot Y, Berhe N, Erko B, Slater HC, Bizilj GT, Barney R, Golden A, Domingo GJ, Golassa L. Performance of a Novel Plasmodium falciparum Rapid Diagnostic Test in Areas of Widespread hrp2/3 Gene Deletion. Clin Infect Dis. 2026 Feb 4;81(6):e491-e501. doi: 10.1093/cid/ciaf212.
- Individual participant dataSharing planned: No
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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.
Dr. Lemu Golassa, PhD principal investigator
Addis Ababa University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NxTekTM Malaria Pf Plus Rapid Diagnostic Test Device in people with Malaria, run by Abbott Rapid Dx at 1 site in Ethiopia.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 24 Apr 2023. 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 Ethiopia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the sensitivity, specificity, positive and negative predicting values (PPV and NPV) [altogether referred to hereafter as "diagnostic accuracy"] of NxTekTM Malaria Pf Plus (time frame: 6 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?
On the ClinicalTrials.gov record for NCT05286359, which also lists 1 linked publication.
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 24 Apr 2023.