NCT07456969

Non-invasive Malaria Diagnostic Data Collection in Ethiopia

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Foundation for Innovative New Diagnostics, Switzerland · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Malaria Fever

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-07-01
• Completion: 2026-09-01
• First posted: 2026-03-09
• Last updated: 2026-03-09