Non-invasive Malaria Diagnostic Data Collection in Ethiopia

NCT07456969 | Recruiting

• 1 other identifier: MA019
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Malaria Fever

Outcome Measures

Primary Outcomes (1)

• 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.

  From June 2026 to September 2026

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Foundation for Innovative New Diagnostics, Switzerland: lead

Study Sites (1)

Maraki

Gonder, Amhara, 6200, Ethiopia

RECRUITING

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Ayalew Jejaw Zeleke

  University of Gondar

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andres De la Rossa, PhD

CONTACT

+41 798814705; andres.delarossa@finddx.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 9, 2026
• Study Start: August 7, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 4, 2026

Record last verified: 2026-09

Locations

ET (1)