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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
Interventional
Source
PACTR
Registry ID
PACTR202202766889963
Enrollment
4500
Registered
2022-02-01
Start date
2021-07-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Malaria

Interventions

Sponsors

Academic Medical Centre at the University of Amsterdam
Lead Sponsor

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

Design outcomes

Primary

MeasureTime frame
For each diagnostic test studied we will report sensitivity, specificity, negative and positive predictive values

Secondary

MeasureTime frame
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.

Countries

Burkina Faso, Ethiopia, Kenya, Namibia, Sudan

Contacts

Public ContactPetra Mens

Head of Malaria Research

p.f.mens@amsterdamumc.nl+31205665454

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026