Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Could a simple breath test replace needles for malaria diagnosis?

NCT ID NCT07456969

Diagnosis Sponsor: Foundation for Innovative New Diagnostics, Switzerland Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 04, 2026 · Updated 2 times

Summary

This study aims to validate a non-invasive malaria diagnostic tool that detects specific compounds in breath, called volatile organic compounds (VOCs), using a device called TRACE-E. Researchers will collect breath and blood samples from 200 people aged 12 and older with fever in Ethiopia. If the breath test accurately matches PCR blood test results, it could pave the way for rapid, painless malaria screening without needles.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TRACE-E device (breath analysis for VOC biomarkers)
What this could lead to
If successful, this could lead to a quick, painless breath test for malaria, replacing needles and blood draws.
What could go wrong
This is an early validation study with only 200 participants. The VOC biomarkers may not reliably distinguish malaria from other fevers, and the device may not be accurate enough for real-world use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Malaria fever are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

malaria

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Malaria fever

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Maraki

    RECRUITING

    Gonder, Amhara, 6200, Ethiopia

More trials for these conditions

Other studies related to the condition(s) this trial covers.