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NCT Number: NCT07456969

Non-invasive Malaria Diagnostic Data Collection in Ethiopia

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.

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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Endpoint 1

    Time frame: From June 2026 to September 2026

    Detection rate of the six predefined malaria VOC biomarkers in breath from PCR-confirmed malaria-positive and negative participants, as measured by TRACE-E.

Study contacts

Contact information is provided by the study sponsor or research team.

Andres De la Rossa, PhD

CONTACT

[email protected]

+41 798814705

Sponsors and collaborators

Lead sponsor

Foundation for Innovative New Diagnostics, Switzerland

Other

Registry information

Official study title

Data Collection Support for a Non-invasive Malaria Diagnostic Tool Using Volatile Organic Compounds (VOC) in Gondar, Ethiopia

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 9, 2026
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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