Non-invasive malaria breath test data collection in Ethiopia
Official title: Data Collection Support for a Non-invasive Malaria Diagnostic Tool Using Volatile Organic Compounds (VOC) in Gondar, Ethiopia
Run by Foundation for Innovative New Diagnostics, Switzerland · NCT07456969 · Data updated 2026-11-12
Researchers are testing a breath-based, non-blood method to detect malaria in people 12 and older who have fever, to see if specific breath compounds can signal infection.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 12 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Foundation for Innovative New Diagnostics, Switzerland Academic / other |
| Locations | 1 site (Gonder, Amhara) |
| Status | Recruiting |
| Started | August 7, 2026 |
| Main results expected | November 30, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | September 4, 2026 |
| Trial ID | NCT07456969 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals aged 12 or older with fever (≥37.5°C) presenting at the site and able to provide informed consent or assent.
✕Probably not a fit
Patients with severe illness, respiratory conditions that impede breath collection, recent antimalarial treatment within 14 days, or inability to comply with study procedures may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational project collects breath samples from individuals suspected of malaria at Gondar University in Ethiopia to validate links between volatile organic compounds and malaria infection using a thermodynamic sensor platform. Six candidate VOC biomarkers have been identified, with two ready to be detected by the TRACE-E device and others under evaluation. The study aims to gather robust clinical data from well-characterized samples to strengthen the diagnostic algorithm without requiring invasive sampling. Participation involves consent and assent where applicable, and excludes those with severe illness or conditions that impair breath collection. Lead sponsorship comes from the Foundation for Innovative New Diagnostics (Swiss), with the study site at Maraki/Gondar in Amhara.
Why it matters
Potential benefit: If successful, the approach could enable rapid, painless malaria screening without drawing blood.
How similar studies have gone: Previous work has identified malaria-related VOCs and shown feasibility in breath-based detection, but robust clinical validation remains needed for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: Aged 12 years or older Presenting at the study site with fever (37.5 degrees and above) Freely agreeing to participate by providing informed consent (and assent, if applicable) Exclusion Criteria: Presence of symptoms and signs of severe illness and/or central nervous system infections. Presenting with any condition that prevents adequate breath collection: Asthma Chronic Obstructive Pulmonary Disease (COPD) Severe respiratory illness Inability to follow instructions Patient lacking capacity to provide informed consent. Prior antimalarial treatment within the last 14 days.
Where it's running
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Maraki
Gonder, Amhara, Ethiopia Recruiting
Study contacts
- Principal investigator: Ayalew Jejaw Zeleke — University of Gondar
- Study coordinator: Andres De la Rossa, PhD
- Email: andres.delarossa@finddx.org
- Phone: +41 798814705
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.