Monkeypox ASymptomatic Shedding: Evaluation by Self-Sampling MPX-ASSESS

NCT ID: NCT05443867

Last Updated: 2023-09-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 27 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-22
• Study Completion Date: 2022-08-25

Brief Summary

Monkeypox (MPX) is a viral zoonosis, caused by the Monkeypox virus (MPXV), a DNA virus that belongs to the Orthopoxvirus genus and is closely related to the variola virus, the causative agent of smallpox. Until recently the spread of MPX was mainly confined to the Central African rainforest and to parts of West Africa. However, in May 2022, several cases of MPX were detected throughout Europe and Northern America, albeit with a different presentation than previously seen. Many questions remain on this new presentation of the disease: what the exact mode of transmission is, how contagious the virus really is and whether asymptomatic carriers exist. With this study the researchers aim to perform a close follow-up study of close contacts of MPX confirmed cases. Participants are recruited among high and very high risk contacts of confirmed monkeypox patients that presented to the ITM for diagnosis (index). Contacts that are asymptomatic (for symptoms compatible with MPXV infection according to national case definitions) at the time of recruitment will be enrolled. Contacts of the index case that are symptomatic at recruitment or become symptomatic during follow-up will be invited for sample collection at different timepoints until 21 days after contact as suspect cases.

Conditions

Monkey Pox

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

MPX-Assess

Contacts of MPX index cases

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Be a high risk or very high-risk contact of a laboratory confirmed monkeypox case, with:

• Very high-risk contact:

• Sexual partner(s)
• Prolonged skin-to-skin contact while the patient had skin lesions
• High risk contact

• living in the same household or similar environment (e.g. camping, spending the night, etc.);
• shared clothing, bedding, utensils, etc., while the patient had skin lesions
• healthcare workers with unprotected contact (inadequate or no PPE)

2. Last exposure to the monkeypox index case of less than 21 days ago

3. Adult participants (≥ 18 years old) of any gender

4. Written informed consent is obtained from the participant

Exclusion Criteria

1. Presenting with symptoms compatible with MPX:

• an unexplained rash on any part of the body AND
• one or more of the following symptoms: fever, headache, back pain, fatigue, lymphadenopathy (localised or generalised)

2. Inability or unwillingness to comply with the proposed follow-up schedule

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institute of Tropical Medicine, Belgium

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurens Liesenborghs, MD

Role: PRINCIPAL_INVESTIGATOR

Instituut van Tropische Geneeskunde Antwerpen

Locations

Institute of Tropical Medicine Antwerp

Antwerp, , Belgium

Countries

Belgium

References

Brosius I, Van Dijck C, Coppens J, Vandenhove L, Bangwen E, Vanroye F, Verschueren J; ITM MPOX Study Group; Zange S, Bugert J, Michiels J, Bottieau E, Soentjens P, van Griensven J, Kenyon C, Arien KK, Van Esbroeck M, Vercauteren K, Liesenborghs L. Presymptomatic viral shedding in high-risk mpox contacts: A prospective cohort study. J Med Virol. 2023 May;95(5):e28769. doi: 10.1002/jmv.28769.

Reference Type: DERIVED

PMID: 37212312 (View on PubMed)

Other Identifiers

MPX-Assess

Identifier Type: -

Identifier Source: org_study_id