Mpox (Monkeypox)DiagRaMIE MpoxNCT06840197
DiagRaMIE Mpox Virus-RDC for the Diagnostic of Monkeypox
An observational study of Mpox (Monkeypox) and Monkeypox Virus Infection, run by Assistance Publique - Hôpitaux de Paris at 3 sites in Republic of the Congo.
Trial summary
Monkeypox, caused by a virus in the Orthopoxvirus genus, is a zoonotic disease first identified in 1970 in the Democratic Republic of Congo (DRC). This infection, primarily present in Central and West Africa, has an incubation period of 6 to 21 days and initially presents with fever, headaches, muscle pain, and… Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Mpox (Monkeypox), Monkeypox Virus Infection
- What is being tested?
- NG-TestⓇ Monkeypox virus kit
- How many people
- 197 participants
- Where
- 3 sitesRepublic of the Congo
- Study dates
- Feb 2025to May 2025
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Any person showing signs and symptoms, vesicles, and pustules consistent with the WHO definition of suspected Mpox cases
Who may be able to join
- Any person showing signs and symptoms, vesicles, and pustules consistent with the WHO definition of suspected Mpox cases (https://www.who.int/fr/publications-detail/WHO-MPX-Surveillance-2022.3)
- Persons aged 2 years and older:
- An adult capable of providing informed consent to participate in the study
- The legal guardian(s) capable of providing informed consent for the minor's participation in the study. For minors aged 12 to 17, their assent will also be required
Who cannot join
- Refusal to participate by the individual or their legal guardian(s)
- Person not capable of giving informed consent
- Person with symptoms that appeared more than 14 days ago
- Person presenting only with macules, papules, and crusts
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Republic of the Congo3 sites
INRB
Bukavu, Sud-Kivu
Placide MBALA, PhD, +243 992 121 236, placidembala@inrb.net
INRB
Gemena, Sud Ubangi
Placide MBALA, PhD, +243 992 121 236, placidembala@inrb.net
INRB
Mbandaka, Equateur
PLACIDE MBALA, PhD, +243 992 121 236, placidembala@inrb.net
About this study
Official title: Evaluation of Rapid Diagnostic Solutions for Emerging Infectious Diseases and CBRN Threats - Mpox Virus Clinical Study in the Democratic Republic of the Congo - DiagRaMIE-Mpox Virus-DRC
Monkeypox, caused by a virus in the Orthopoxvirus genus, is a zoonotic disease first identified in 1970 in the Democratic Republic of Congo (DRC). This infection, primarily present in Central and West Africa, has an incubation period of 6 to 21 days and initially presents with fever, headaches, muscle pain, and swollen lymph nodes. This is followed by a skin rash that evolves over 2 to 3 weeks. Lesions can spread from the face to the hands, feet, and mucous membranes, with a centrifugal distribution pattern. Diagnosis is performed using PCR, based on samples taken from lesions or cutaneous exudates, although oropharyngeal swabs may be required if skin lesions are absent.
Since May 2022, a resurgence of cases has been observed in North America, Europe, and Africa, including the DRC. As of March 2024, 94,270 cases and 178 deaths have been reported. Although less lethal than smallpox, with a mortality rate of 1% to 10% depending on the region, monkeypox remains a health threat, especially for young children and immunocompromised individuals. In response, the Commissariat à l'Énergie Atomique (CEA) and NG Biotech have developed the NG-TestⓇ Monkeypox virus rapid diagnostic test to facilitate detection. This antigenic immunochromatographic test, based on clinical samples, offers an alternative to PCR, providing rapid results without the need for costly equipment or specialized expertise. Its validation is underway for CE marking, enabling a swift response to potential health crises.
Preclinical trials have confirmed that this test detects the Mpox virus with a detection limit of 1.10⁴ pfu/mL and shows no cross-reaction with other common organisms. This clinical performance study aims to determine the effectiveness of this device using prospectively collected clinical samples. The study seeks to validate this rapid diagnostic test (RDT) and support its CE marking. Thus, this test could serve as an alternative to conventional PCR diagnostics, which require several hours to process and necessitate costly specialized equipment and expertise.
Read the detailed description
The DiagRaMIE project is designed to aid in the prevention and control of emerging or re-emerging infectious diseases and to support effective responses to potential new pandemics. Its main objective is to develop rapid diagnostic immunological tests (RDTs) for priority pathogens identified by the WHO, including the Mpox virus. Recently, monkeypox (Mpox) cases have been reported concurrently in non-endemic countries (Europe and America) and endemic regions (West and Central Africa). In response, the CEA and NG Biotech have developed an RDT to help curb potential transmission. Since its deployment, the number of cases in Europe has dropped considerably, though Mpox remains a significant health concern in Africa, especially in the Democratic Republic of Congo (DRC). This clinical performance study aims to validate a reliable diagnostic tool for both ongoing and potential future Mpox epidemics.
Objectives of the Clinical Performance Study The primary goal of this clinical performance study is to prospectively assess the effectiveness of the NG-TestⓇ Monkeypox virus kit, an RDT developed by CEA and NG Biotech, in diagnosing suspected Mpox cases. The test is based on prospective immunochromatography, with this study serving to support its CE marking.
Primary Evaluation Endpoint The primary endpoint is the participant's Mpox virus infection status, determined through PCR testing using the Xpert® Mpox kit (Cepheid), which is the reference diagnostic test (Gold Standard).
Study Design This is a prospective, multicenter study aimed at validating the diagnostic accuracy of the new RDT. Participants will include symptomatic patients suspected of Mpox infection. Each participant will undergo both the reference PCR test (Xpert® Mpox kit, Cepheid) and the newly developed RDT by CEA and NG Biotech.
Target Population Patients presenting at health facilities with signs and symptoms suggestive of Mpox will be prospectively recruited by healthcare workers. After providing information about the study and obtaining consent (from either the patient or legal guardians for minors), demographic and medical data will be collected, and two samples of vesicular exudate will be taken in addition to the routine diagnostic samples. Number of subjects declared to the insurer (having signed consent): maximum 197 patients in order to have 167 evaluable patients International Research Scope This international study will take place in the Democratic Republic of Congo, specifically in regions with high disease incidence: South Kivu, Equateur, and South Ubangi. Initially, the protocol will focus on these regions. However, if outbreaks emerge elsewhere, the study may be expanded to include additional affected areas, with participants recruited from those regions as well.
Study Duration The clinical study is planned to last for six months.
- Conditions
- Mpox (Monkeypox), Monkeypox Virus Infection
- Being tested
- NG-TestⓇ Monkeypox virus kit
- Keywords
- Mpox, Monkeypox virus, Rapid Diagnostic Test (RDT)
- Medical subject headings
- Mpox, Monkeypox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NG-TestⓇ Monkeypox virus kitDiagnostic test
Evaluation of the performance of the rapid diagnostic test (RDT) for the detection of the Mpox virus (NG-TestⓇ Monkeypox virus kit) and comparision with PCR result (reference test)
What is being measured
The primary outcome is the main question the study is designed to answer.
To prospectively evaluate the performance of the rapid diagnostic test (RDT) for the detection of the Mpox virus (NG-TestⓇ Monkeypox virus kit), developed by the CEA and NG Biotech, based on the immunochromatography method in a prospective manner
The results of the NG-TestⓇ Monkeypox virus kit will be obtained within 20 minutes (5 minutes for sampling + 15 minutes for the test) after the patient is included in the study, and these results will be compared to the PCR result, which usually requires 48 hours
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study startFeb 2025 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mpox (Monkeypox)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 197 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- NG Biotech, Commissariat A L'energie Atomique
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06840197
- Sponsor's protocol ID
- APHP 2310044
- Acronym
- DiagRaMIE Mpox
- Status last verified
- Nov 2024
- First submitted
- 17 Feb 2025
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Rapid Diagnostic Solutions for Emerging Infectious Diseases and CBRN Threats - Mpox Virus Clinical Study in the Democratic Republic of the Congo - DiagRaMIE-Mpox Virus-DRC
- ClinicalTrials.gov ID
- NCT06840197
- Acronym / sponsor ID
- DiagRaMIE Mpox / APHP 2310044
- Conditions
- Mpox (Monkeypox), Monkeypox Virus Infection
- Keywords
- Mpox, Monkeypox virus, Rapid Diagnostic Test (RDT)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 197 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- NG Biotech, Commissariat A L'energie Atomique
- Study start
- Feb 2025 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 21 Feb 2025 (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.
Monkeypox, caused by a virus in the Orthopoxvirus genus, is a zoonotic disease first identified in 1970 in the Democratic Republic of Congo (DRC). This infection, primarily present in Central and West Africa, has an incubation period of 6 to 21 days and initially presents with fever, headaches, muscle pain, and swollen lymph nodes. This is followed by a skin rash that evolves over 2 to 3 weeks. Lesions can spread from the face to the hands, feet, and mucous membranes, with a centrifugal distribution pattern. Diagnosis is performed using PCR, based on samples taken from lesions or cutaneous exudates, although oropharyngeal swabs may be required if skin lesions are absent.
Since May 2022, a resurgence of cases has been observed in North America, Europe, and Africa, including the DRC. As of March 2024, 94,270 cases and 178 deaths have been reported. Although less lethal than smallpox, with a mortality rate of 1% to 10% depending on the region, monkeypox remains a health threat, especially for young children and immunocompromised individuals. In response, the Commissariat à l'Énergie Atomique (CEA) and NG Biotech have developed the NG-TestⓇ Monkeypox virus rapid diagnostic test to facilitate detection. This antigenic immunochromatographic test, based on clinical samples, offers an alternative to PCR, providing rapid results without the need for costly equipment or specialized expertise. Its validation is underway for CE marking, enabling a swift response to potential health crises.
Preclinical trials have confirmed that this test detects the Mpox virus with a detection limit of 1.10⁴ pfu/mL and shows no cross-reaction with other common organisms. This clinical performance study aims to determine the effectiveness of this device using prospectively collected clinical samples. The study seeks to validate this rapid diagnostic test (RDT) and support its CE marking. Thus, this test could serve as an alternative to conventional PCR diagnostics, which require several hours to process and necessitate costly specialized equipment and expertise.
Detailed description
The DiagRaMIE project is designed to aid in the prevention and control of emerging or re-emerging infectious diseases and to support effective responses to potential new pandemics. Its main objective is to develop rapid diagnostic immunological tests (RDTs) for priority pathogens identified by the WHO, including the Mpox virus. Recently, monkeypox (Mpox) cases have been reported concurrently in non-endemic countries (Europe and America) and endemic regions (West and Central Africa). In response, the CEA and NG Biotech have developed an RDT to help curb potential transmission. Since its deployment, the number of cases in Europe has dropped considerably, though Mpox remains a significant health concern in Africa, especially in the Democratic Republic of Congo (DRC). This clinical performance study aims to validate a reliable diagnostic tool for both ongoing and potential future Mpox epidemics.
Objectives of the Clinical Performance Study The primary goal of this clinical performance study is to prospectively assess the effectiveness of the NG-TestⓇ Monkeypox virus kit, an RDT developed by CEA and NG Biotech, in diagnosing suspected Mpox cases. The test is based on prospective immunochromatography, with this study serving to support its CE marking.
Primary Evaluation Endpoint The primary endpoint is the participant's Mpox virus infection status, determined through PCR testing using the Xpert® Mpox kit (Cepheid), which is the reference diagnostic test (Gold Standard).
Study Design This is a prospective, multicenter study aimed at validating the diagnostic accuracy of the new RDT. Participants will include symptomatic patients suspected of Mpox infection. Each participant will undergo both the reference PCR test (Xpert® Mpox kit, Cepheid) and the newly developed RDT by CEA and NG Biotech.
Target Population Patients presenting at health facilities with signs and symptoms suggestive of Mpox will be prospectively recruited by healthcare workers. After providing information about the study and obtaining consent (from either the patient or legal guardians for minors), demographic and medical data will be collected, and two samples of vesicular exudate will be taken in addition to the routine diagnostic samples. Number of subjects declared to the insurer (having signed consent): maximum 197 patients in order to have 167 evaluable patients International Research Scope This international study will take place in the Democratic Republic of Congo, specifically in regions with high disease incidence: South Kivu, Equateur, and South Ubangi. Initially, the protocol will focus on these regions. However, if outbreaks emerge elsewhere, the study may be expanded to include additional affected areas, with participants recruited from those regions as well.
Study Duration The clinical study is planned to last for six months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any person showing signs and symptoms, vesicles, and pustules consistent with the WHO definition of suspected Mpox cases
Key inclusion criteria (4 listed)
- Any person showing signs and symptoms, vesicles, and pustules consistent with the WHO definition of suspected Mpox cases (https://www.who.int/fr/publications-detail/WHO-MPX-Surveillance-2022.3)
- Persons aged 2 years and older:
- An adult capable of providing informed consent to participate in the study
- The legal guardian(s) capable of providing informed consent for the minor's participation in the study. For minors aged 12 to 17, their assent will also be required
Key exclusion criteria (4 listed)
- Refusal to participate by the individual or their legal guardian(s)
- Person not capable of giving informed consent
- Person with symptoms that appeared more than 14 days ago
- Person presenting only with macules, papules, and crusts
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 |
|---|---|---|
| NG-TestⓇ Monkeypox virus kitEvaluation of the performance of the rapid diagnostic test (RDT) for the detection of the Mpox virus (NG-TestⓇ Monkeypox virus kit) and comparision with PCR result (reference test) | Diagnostic test | – |
Primary outcome
To prospectively evaluate the performance of the rapid diagnostic test (RDT) for the detection of the Mpox virus (NG-TestⓇ Monkeypox virus kit), developed by the CEA and NG Biotech, based on the immunochromatography method in a prospective manner
Time frame: 48 hours
The results of the NG-TestⓇ Monkeypox virus kit will be obtained within 20 minutes (5 minutes for sampling + 15 minutes for the test) after the patient is included in the study, and these results will be compared to the PCR result, which usually requires 48 hours
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 21 Feb 2025.
- Individual participant dataSharing planned: No
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mpox (Monkeypox) and Monkeypox Virus Infection, run by Assistance Publique - Hôpitaux de Paris at 3 sites in 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 4 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: opening soon, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in 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?
Contact Thierry NAAS, PhD (1 45 21 29 86 ext. 33, thierry.naas@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To prospectively evaluate the performance of the rapid diagnostic test (RDT) for the detection of the Mpox virus (NG-TestⓇ Monkeypox virus kit), developed by the CEA and NG Biotech, based on the immunochromatography method in a prospective manner (time frame: 48 hours). 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 21 Feb 2025.