Evaluation of a new and simple diagnostic test for malaria

Phase 3 evaluation of an innovative simple molecular test for the diagnosis of malaria in different endemic and health settings in sub-Saharan Africa

Status

Recruiting

Phases

Phase 3

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN13334317

Enrollment

4500

Registered

2022-02-22

Start date

2021-12-01

Completion date

Unknown

Last updated

2023-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria (uncomplicated Plasmodium falciparum malaria) Infections and Infestations

Interventions

Comparison of different diagnostic tests for malaria. Diagnostic performance will be assessed following the WHO/TDR guidelines for the evaluation of diagnostics and the results will be reported accor

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: In Sudan, Ethiopia, Burkina Faso and Kenya, the study will include patients who fulfil the following inclusion criteria: 1. Potential participant (patients with clinical suspicion of malaria) of all ages presenting at the health facility; 2. Coming from the health centre catchment area; 3. Informed consent from patient or of parents/guardians (in case of minors). In Namibia, the study will include persons who fulfil the following criteria: 1. Be a resident of one of the selected households or have slept the night before in this household. 2. Informed consent from potential participants (individually).

Exclusion criteria

Exclusion criteria: Not meeting the above inclusion criteria, depending on study site.

Design outcomes

Primary

Measure	Time frame
Diagnostic accuracy measured as sensitivity, specificity, negative and positive predictive value of index test (dbPCR-NALFIA) compared to reference (standard) tests at point of diagnostic testing (enrolment of study case)	—

Secondary

Measure	Time frame
1. To determine the direct and indirect costs and benefits of allocating limited resources to implement the mini-dbPCR-NALFIA test for malaria compared to current diagnostic strategies in place. Descriptive outcome measured as availability of a report at the end of the trial 2. To determine potential barriers to successfully implement the new diagnostic platform within local, socio-economic and cultural contexts under routine conditions. Descriptive outcome measured as availability of a report at the end of the trial 3. To build a draft product dossier for CE marking and pre-qualification and to identify potential producers that can bring the platform to the market (exploitation objective). Effectiveness of dossier drafting is measured by the availability of a draft product dossier at the end of the trial 4. To strengthen the capacity of all five African partners in the field of diagnostic clinical trials, including Good Clinical and Laboratory Practices (GC/LP) training of research and auxiliary staff and prospective MSc/ PhD students, and to improve the research infrastructure at the trial sites. Effectiveness of capacity building is measured as number of staff trained at the end of the trial. 5. To disseminate the outcomes of the project to stakeholders, including scientific peers, diagnostic entities, policy makers and the lay public. Effectiveness of dissemination is measured as number of publications in peer reviewed journals at the end of the trial	—

Measure

Time frame

1. To determine the direct and indirect costs and benefits of allocating limited resources to implement the mini-dbPCR-NALFIA test for malaria compared to current diagnostic strategies in place. Descriptive outcome measured as availability of a report at the end of the trial 2. To determine potential barriers to successfully implement the new diagnostic platform within local, socio-economic and cultural contexts under routine conditions. Descriptive outcome measured as availability of a report at the end of the trial 3. To build a draft product dossier for CE marking and pre-qualification and to identify potential producers that can bring the platform to the market (exploitation objective). Effectiveness of dossier drafting is measured by the availability of a draft product dossier at the end of the trial 4. To strengthen the capacity of all five African partners in the field of diagnostic clinical trials, including Good Clinical and Laboratory Practices (GC/LP) training of research and auxiliary staff and prospective MSc/ PhD students, and to improve the research infrastructure at the trial sites. Effectiveness of capacity building is measured as number of staff trained at the end of the trial. 5. To disseminate the outcomes of the project to stakeholders, including scientific peers, diagnostic entities, policy makers and the lay public. Effectiveness of dissemination is measured as number of publications in peer reviewed journals at the end of the trial

—

Countries

Burkina Faso, Ethiopia, Kenya, Namibia, Sudan

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 13, 2026