NCT05085301 is a clinical trial of Rapid diagnostic test in Malaria, sponsored by Foundation for Innovative New Diagnostics, Switzerland.

Who is sponsoring NCT05085301?

NCT05085301 is sponsored by Foundation for Innovative New Diagnostics, Switzerland.

What drugs are being tested in NCT05085301?

Interventions in NCT05085301: Rapid diagnostic test.

What condition does NCT05085301 study?

NCT05085301 studies Malaria, Diagnoses Disease, RDT.

Is NCT05085301 still recruiting?

NCT05085301 is currently completed. Last updated 13 October 2023.

Last reviewed 2023-10-13 · How we verify

NCT05085301

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

RapiGEN BIOCREDIT Malaria Ag RDTs WHO Prequalification Study

Completed Last updated 13 October 2023

What this trial tests

trial testing Rapid diagnostic test in Malaria in 674 participants. Completed in 30 May 2023.

Timeline

1 December 2021

Primary endpoint
30 May 2022

30 May 2023

Quick facts

Lead sponsor	Foundation for Innovative New Diagnostics, Switzerland
Status	Completed
Study type	OBSERVATIONAL
Enrollment	674
Start date	1 December 2021
Primary completion	30 May 2022
Estimated completion	30 May 2023
Sites	2 locations across Indonesia, Sudan

Drugs / interventions tested

Rapid diagnostic test

Conditions studied

Malaria — all drugs for Malaria →
Diagnoses Disease — all drugs for Diagnoses Disease →
RDT — all drugs for RDT →

Sponsor

Foundation for Innovative New Diagnostics, Switzerland

Who can join

5 and older, any sex, with Malaria or Diagnoses Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Since their introduction in the late 90's, rapid diagnostic tests (RDTs) have markedly improved our ability to control malaria; yet they have inherent limitations which include low sensitivity in Plasmodium vivax detection and inability to detect hrp2/3 gene deleted Plasmodium falciparum parasites. In addition, the spread of P. falciparum parasites lacking hrp2 gene jeopardizes the long-term use of P. falciparum-specific HRP2-based RDTs. A partnership between RapiGEN, FIND, and the Bill and Melinda Gates Foundation (BMGF) is addressing these limitations by developing five novel malaria RDTs with improved pLDH and HRP2 detection. RapiGEN has also developed three novel malaria RDTs - BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH), BIOCREDIT Malaria Ag Pf (pLDH/HRP2) and BIOCREDIT Malaria Ag Pf (pLDH) - to address these drawbacks. The BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH) is a combo test that detects P. falciparum and P. vivax on a single device. BIOCREDIT Malaria Ag Pf (pLDH/HRP2) targets both PfLDH and HRP2 antigens in P. falciparum; and BIOCREDIT Malaria Ag Pf (pLDH) has improved detection of pLDH in P. falciparum. In countries with circulation of hrp2/3 deleted P. falciparum malaria parasites or high P. vivax burden, these improved RDTs may be invaluable in malaria elimination. This study is a prospective and retrospective evaluation of RapiGEN's BIOCREDIT Malaria Ag RDTs in malaria-endemic countries to assess their clinical performance for detection of malaria. The purpose of this study is to provide a high level outline of the study design and conduct to support the collation of a data package for WHO Pre-Qualification proposed study.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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 Foundation for Innovative New Diagnostics, Switzerland trials

Trials by the same sponsor.

NCT06213051 — Comparison of Self-collection Using Dry Compared to Wet Swabs for HPV Detection · unknown
NCT05944731 — Use of Continuous Glucose Monitoring Devices Among People Living With Type 1 Diabetes in Kenya. · NA · unknown
NCT06118749 — Leishmania Antigen Rapid Diagnostic Test Proof-of-Concept and Validation Study · terminated
NCT05944718 — Use of Continuous Glucose Monitoring Devices Among People Living With Type 1 Diabetes in South Africa · NA · completed
NCT06170515 — BGM and HbA1c POC Device Evaluation · NA · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05085301 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Foundation for Innovative New Diagnostics, Switzerland
Last refreshed: 13 October 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/NCT05085301.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing