An observational study in Malaria Fever, sponsored by Foundation for Innovative New Diagnostics, Switzerland. Recruiting at 1 site in Ethiopia. Open to participants aged 12 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Foundation for Innovative New Diagnostics, Switzerland · Observational
This project supports the development of a non-invasive diagnostic tool for malaria, focusing on validating the link between VOCs (volatile organic compounds) and malaria infection using thermodynamic sensors. This technology aims to provide rapid, painless alternatives to blood-based diagnostics, enabling malaria detection without invasive sampling.
Trace Sensing has already identified six potential VOC biomarkers based on published literature specific for malaria. Two of these are part of the company's existing library and can already be detected in purified form by the TRACE-E device, while the others are under active evaluation. To confirm the suitability of the selected VOC biomarkers for diagnosing malaria and strengthen the detection algorithm, high-quality, robust clinical data from well-characterized biological specimens are required. In partnership with Gondar University in Ethiopia, breath samples will be collected from individuals (12 years and older) suspected of having malaria presenting at two health clinics. PCR performed on blood samples will serve as reference method to confirm infection status, while non-invasive clinical breath tests will be performed using the TRACE-E device.
The resulting data will confirm whether the six candidate malaria VOC biomarkers can be detected in patient breath, and if other VOC biomarkers can be detected as well. This study will therefore act as a malaria VOC biomarker confirmation study.
1,184 studies on the registry are indexed under Malaria; 79 are open to participants now.
This study's planned enrollment of 200 is below the median of 582 across 204 observational studies indexed under Malaria.
Browse Malaria studies →Foundation for Innovative New Diagnostics, Switzerland is the lead sponsor of 61 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population consists of individuals aged 12 years and older presenting to outpatient clinics in Gondar, Ethiopia with suspected malaria.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Aged 12 years or older
Presenting at the study site with fever (37.5 degrees and above)
Freely agreeing to participate by providing (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
(COPD)
Severe respiratory illness
Inability to follow instructions
Patient lacking capacity to provide .
Prior antimalarial treatment within the last 14 days.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Endpoint 1
Detection rate of the six predefined malaria VOC biomarkers in breath from PCR-confirmed malaria-positive and negative participants, as measured by TRACE-E.
Time frame: From June 2026 to September 2026
Started Aug 2026 (actual). Primary completion is estimated for Nov 2026, 3 months after the start.
Of 85 non-industry observational studies under Malaria, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 36. This study's planned 3 months is below that.
Counting every sponsor, half of 93 studies reached it within 24 months; a quarter within 16 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
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Foundation for Innovative New Diagnostics, Switzerland