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

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07456969

Enrollment

200

Registered

2026-03-09

Start date

2026-08-07

Completion date

2026-12-31

Last updated

2026-09-04

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

Conditions

Malaria Fever

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Endpoint 1	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.

Countries

Ethiopia

Contacts

CONTACTAndres De la Rossa, PhD

andres.delarossa@finddx.org+41 798814705

PRINCIPAL_INVESTIGATORAyalew Jejaw Zeleke

University of Gondar

Outcome results