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Could a simple paper strip revolutionize mpox testing?

NCT ID NCT07634081

Diagnosis Sponsor: Universitaire Ziekenhuizen KU Leuven 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new way to collect and transport samples for mpox diagnosis using a special paper strip treated with SDS and EDTA. The strip inactivates the virus, making transport safer, and stabilizes the genetic material so cold storage isn't needed. Researchers will compare this method to the usual swab method in 150 patients in the Democratic Republic of the Congo to see if it works just as well.

What this could mean

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

Active substance
SDS-EDTA-treated chromatography strip
What this could lead to
If successful, this could provide a simpler, safer way to collect and transport mpox samples without needing cold storage, making diagnosis easier in remote areas.
What could go wrong
This is a small, early-stage study (150 participants) comparing a new method to standard swabs. The new method may not be as accurate or practical in real-world settings.

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 150 people

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

Started

May 2026

Expected to finish

Jul 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

Patients with suspected mpox infection in South Kivu, DRC.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Patients presenting with clinical signs compatible with mpox infection according to national case definition. * Written informed consent obtained. * Presence of at least two skin lesions in a similar stage of evolution suitable for paired sampling. Exclusion Criteria: * Refusal or inability to provide informed consent. * Presence of only one suitable lesion for sampling. * Lesions at markedly different stages of evolution. * Inability to safely obtain paired samples.

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Conditions

The condition(s) this trial relates to.

monkeypox

As listed by the trial registrant

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

Mpox

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

  • Miti-Murhesa General Referral Hospital and affiliated healthcare facilities in South Kivu

    RECRUITING

    Bukavu, Democratic Republic of the Congo

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