Last reviewed · How we verify
NCT05286359
Performance Evaluation of Malaria Plus Rapid Diagnostic Tests (RDTs) for the Detection of Plasmodium Infections in Patients With Symptoms Suggestive of Malaria
NA trial testing NxTekTM Malaria Pf Plus Rapid Diagnostic Test Device in Malaria in 1,023 participants. Completed in 17 November 2022.
17 November 2022
Quick facts
| Lead sponsor | Abbott Rapid Dx |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 1,023 |
| Start date | 24 May 2022 |
| Primary completion | 17 November 2022 |
| Estimated completion | 17 November 2022 |
| Sites | 1 location across Ethiopia |
Drugs / interventions tested
- NxTekTM Malaria Pf Plus Rapid Diagnostic Test Device
Conditions studied
- Malaria — all drugs for Malaria →
Sponsor
Abbott Rapid Dx
Who can join
5 and older, any sex, with Malaria. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Performance of a Novel Plasmodium falciparum Rapid Diagnostic Test in Areas of Widespread hrp2/3 Gene Deletion.
Mandefro A, Ding XC, Farge J, Alemayehu GS, et al · · 2026 · cited 4× · PMID 40274531 · DOI 10.1093/cid/ciaf212
Verify or expand the search:
- PubMed search for NCT05286359
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Malaria
Currently open trials in the same condition.
- NCT07358910 — Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective · recruiting
- NCT07036159 — A Study to Assess the Safety and Immunogenicity of a Vaccine Against Malaria in Healthy Children Aged 5-60 Months · Phase 2 · recruiting
- NCT06735209 — First-in-Human PfSPZ-LARC2 Vaccination/CHMI · Phase 1 · active not recruiting
- NCT06854042 — A Study of Oral E1018 in Healthy Adult Participants · Phase 1 · recruiting
- NCT06607003 — Induced Blood-Stage Malaria in Healthy Malaria-Naive Adults to Assess the Safety and Infectivity of Plasmodium Vivax Cha · Phase 1 · recruiting
Other Abbott Rapid Dx trials
Trials by the same sponsor.
- NCT07203183 — Dengue - Sample Collection Study Pakistan · not yet recruiting
- NCT06928129 — Clinical Feasibility of the BinaxNOW™ COVID-19/Flu A&B Combo in the Southern Hemisphere · NA · not yet recruiting
- NCT06492018 — Lay User Evaluation of the Panbio™ HCV Self Test in an EU Population · not yet recruiting
- NCT06395675 — Clinical Evaluation of the ID NOW™ CT/NG Test · NA · not yet recruiting
- NCT06124638 — Clinical Evaluation of the Panbio™ COVID-19/Flu A&B Panel to Support Home Use · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05286359 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Abbott Rapid Dx
- Last refreshed: 24 April 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05286359.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing