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New rapid tests for respiratory infections put to the test in africa

NCT ID NCT07651865

Diagnosis Sponsor: Karolinska Institutet Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 02, 2026 · Updated 4 times

Summary

This study is testing new rapid tests (lateral flow and microfluidic devices) to detect respiratory infections in children and adults in Uganda, Ethiopia, and Senegal. Researchers want to see if these tests are accurate and easy to use in low-resource clinics. Participants with respiratory symptoms provide samples during one visit; no treatment is given.

What this could mean

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

What this could lead to
If successful, this could lead to affordable, easy-to-use diagnostic tests for respiratory infections in low-resource areas, improving treatment decisions.
What could go wrong
This is an observational study, not a treatment trial. The tests may not be accurate enough or practical in real-world settings. Results are preliminary.

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

1,765 people

The number who actually took part.

Started

Apr 2025

Finished

Aug 2026

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 will enrol symptomatic children aged 6 months to 17 years and adults aged ≥18 years of both sexes presenting to participating hospitals and health centres with suspected upper or lower respiratory tract infections (RTIs). Participants will be recruited in Uganda, Ethiopia, and Senegal from outpatient and inpatient healthcare settings. Eligible participants will present with at least two symptoms consistent with respiratory infection, such as fever, acute cough, shortness of breath, tachypnoea, or loss of smell and/or taste. Participants (or parents/guardians for minors) will provide written informed consent prior to enrolment.

Ages

6 months and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Age ≥ 6 months * Presentation with suspected respiratory tract infection and at least two of the following symptoms: * Fever (axillary temperature ≥37.5°C) or history of fever * New acute cough episode * Shortness of breath * Tachypnoea (fast breathing) * Loss of smell and/or taste * Ability to provide written informed consent (or assent with parent/guardian consent for minors) * For infants (≤1 year), both fever and new acute cough must be present at screening Exclusion Criteria: * Refusal or inability to provide informed consent/assent * Refusal to provide study samples * Severe chronic medical conditions or mental incapacity that, in the opinion of the clinician, would interfere with study participation * Hospitalisation within the previous 2 weeks for reasons unrelated to the current respiratory symptoms * Acute injury, trauma, or poisoning interfering with participation * Chronic cough lasting \>2 weeks, unless tuberculosis is suspected in the LRTI cohort * Antibiotic use within the previous 2 weeks for participants enrolled in the LRTI cohort (Sub-study 2) only

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Conditions

The condition(s) this trial relates to.

respiratory tract infectious disorder

As listed by the trial registrant

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

Lower resp tract infection Upper respiratory infection

Contacts and locations

Locations

  • Armauer Hansen Research Institute (AHRI)

    Addis Ababa, Ethiopia

  • Epicentre Mbarara Research Centre

    Mbarara, Uganda

  • Institut Pasteur de Dakar

    Dakar, Senegal

More trials for these conditions

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