Non-invasive Malaria Diagnostic Data Collection in Ethiopia

March 3, 2026 updated by: Foundation for Innovative New Diagnostics, Switzerland

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

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

The study population consists of individuals aged 12 years and older presenting to outpatient clinics in Gondar, Ethiopia with suspected malaria.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From June 2026 to September 2026

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Foundation for Innovative New Diagnostics, Switzerland

Investigators

  • Principal Investigator: Ayalew Jejaw Zeleke, University of Gondar

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

March 3, 2026

First Submitted That Met QC Criteria

March 3, 2026

First Posted (Actual)

March 9, 2026

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MA019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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