DiagRaMIE Mpox Virus-RDC for the Diagnostic of Monkeypox

NCT06840197 | Not Yet Recruiting

• 1 other identifier: APHP 2310044
• Study Type: observational
• Target: 197
• Locations: 1 country
• Sites: 3

Brief 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 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.

Conditions

Mpox (Monkeypox); Monkeypox Virus Infection

Keywords

Mpox; Monkeypox virus; Rapid Diagnostic Test (RDT)

Outcome Measures

Primary Outcomes (1)

• 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

  48 hours

Interventions

NG-TestⓇ Monkeypox virus kit DIAGNOSTIC_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)

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any person showing signs and symptoms, vesicles, and pustules consistent with the WHO definition of suspected Mpox cases

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• NG Biotech: collaborator
• Commissariat A L'energie Atomique: collaborator

Study Sites (3)

INRB

Mbandaka, Equateur, Republic of the Congo

Location

INRB

Gemena, Sud Ubangi, Republic of the Congo

Location

INRB

Bukavu, Sud-Kivu, Republic of the Congo

Location

Biospecimen

Retention: SAMPLES WITH DNA

vesicle, pus

MeSH Terms

Conditions

Mpox, Monkeypox

Condition Hierarchy (Ancestors)

Poxviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Primate Diseases; Animal Diseases; Rodent Diseases

Central Study Contacts

Thierry NAAS, PhD

CONTACT

1 45 21 29 86; thierry.naas@aphp.fr

Saoussen OUESLATI, PhD

CONTACT

1 45 21 29 86; saoussen.oueslati@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 21, 2025
• Study Start: February 1, 2025
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: February 21, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

RE (3)