MpoxNCT07634081
Validation of SDS-EDTA-Treated Chromatography Paper Strips for Mpox Sampling and Transport in DRC
An observational study of Mpox, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Democratic Republic of the Congo.
Trial summary
The objective of this prospective paired diagnostic comparison study is to evaluate the diagnostic yield and field applicability of SDS-EDTA-treated chromatography paper strips for the collection, transport, and laboratory detection of mpox virus compared with the routine swab-based sampling method under field… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mpox
- What is being tested?
- SDS-EDTA-treated chromatography strip
- How many people
- 150 participants
- Where
- 1 siteDemocratic Republic of the Congo
- Study dates
- 1 May 2026to 31 Jul 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with suspected mpox infection in South Kivu, DRC.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Democratic Republic of the Congo1 site, 1 recruiting
- Recruiting
Miti-Murhesa General Referral Hospital and affiliated healthcare facilities in South Kivu
Bukavu
Leandre Murhula Masirika, +243976256802, leandremurhula@gmail.com
About this study
Official title: Use of SDS/EDTA-Treated Chromatography Strips for Sampling, Transportation and Laboratory Confirmation of Mpox Virus Infection
The objective of this prospective paired diagnostic comparison study is to evaluate the diagnostic yield and field applicability of SDS-EDTA-treated chromatography paper strips for the collection, transport, and laboratory detection of mpox virus compared with the routine swab-based sampling method under field conditions in the Democratic Republic of the Congo (DRC).
The study is conducted among patients with suspected mpox infection presenting to healthcare facilities in South Kivu, DRC. For each participant, paired samples are collected simultaneously using the standard swab method and the SDS-EDTA strip method. Samples are analyzed using locally available molecular diagnostic platforms.
- Conditions
- Mpox
- Being tested
- SDS-EDTA-treated chromatography strip
- Medical subject headings
- Mpox, Monkeypox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SDS-EDTA-treated chromatography stripDiagnostic test
Chromatography strip treated with a buffer containing SDS and EDTA. SDS inactivates the virus and reduces biosafety constraints during transport, while EDTA stabilizes nucleic acids and reduces dependence on cold-chain conditions.
What is being measured
The primary outcome is the main question the study is designed to answer.
Paired difference in mpox positivity between SDS-EDTA strip samples and routine swab samples.
Measured: Laboratory analysis of collected samples up to 6 months after collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start1 May 2026
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MpoxStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Rwanda Biomedical Centre, Erasmus Medical Center, Stansile, Rwanda, Division Provinciale de la Santé, Bukavu, Centre de Recherche en Sciences Naturelles, South Kivu
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07634081
- Sponsor's protocol ID
- S72060
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of SDS/EDTA-Treated Chromatography Strips for Sampling, Transportation and Laboratory Confirmation of Mpox Virus Infection
- ClinicalTrials.gov ID
- NCT07634081
- Acronym / sponsor ID
- S72060
- Conditions
- Mpox
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Rwanda Biomedical Centre, Erasmus Medical Center, Stansile, Rwanda, Division Provinciale de la Santé, Bukavu, Centre de Recherche en Sciences Naturelles, South Kivu
- Study start
- 1 May 2026 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this prospective paired diagnostic comparison study is to evaluate the diagnostic yield and field applicability of SDS-EDTA-treated chromatography paper strips for the collection, transport, and laboratory detection of mpox virus compared with the routine swab-based sampling method under field conditions in the Democratic Republic of the Congo (DRC).
The study is conducted among patients with suspected mpox infection presenting to healthcare facilities in South Kivu, DRC. For each participant, paired samples are collected simultaneously using the standard swab method and the SDS-EDTA strip method. Samples are analyzed using locally available molecular diagnostic platforms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with suspected mpox infection in South Kivu, DRC.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SDS-EDTA-treated chromatography stripChromatography strip treated with a buffer containing SDS and EDTA. SDS inactivates the virus and reduces biosafety constraints during transport, while EDTA stabilizes nucleic acids and reduces dependence on cold-chain conditions. | Diagnostic test | – |
Primary outcome
Paired difference in mpox positivity between SDS-EDTA strip samples and routine swab samples.
Time frame: Laboratory analysis of collected samples up to 6 months after collection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Miti-Murhesa General Referral Hospital and affiliated healthcare facilities in South Kivu
Bukavu, Democratic Republic of the Congo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mpox, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Democratic Republic of the Congo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Democratic Republic of the Congo. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Paired difference in mpox positivity between SDS-EDTA strip samples and routine swab samples. (time frame: Laboratory analysis of collected samples up to 6 months after collection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.