Monkey PoxMPX-AssessNCT05443867
Monkeypox ASymptomatic Shedding: Evaluation by Self-Sampling MPX-ASSESS
An observational study of Monkey Pox, run by Institute of Tropical Medicine, Belgium at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Monkey Pox
- How many people
- 27 participants
- Where
- 1 siteBelgium
- Study dates
- 22 Jun 2022to 25 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.);
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- shared clothing, bedding, utensils, etc., while the patient had skin lesions
- healthcare workers with unprotected contact (inadequate or no PPE)
- Last exposure to the monkeypox index case of less than 21 days ago
- Adult participants (≥ 18 years old) of any gender
- Written informed consent is obtained from the participant
Who cannot join
- 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)
- Inability or unwillingness to comply with the proposed follow-up schedule
Trial locations and contacts
1 site in 1 country.
About this study
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
- Medical subject headings
- Mpox, Monkeypox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MPX-Assess | Contacts of MPX index cases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Secondary attack rate of MPXV infection in contacts, defined by PCR positivity on any sample
Secondary attack rate of MPXV infection in contacts, defined by PCR positivity on any sample
Measured: Until 21 days after contact with index case
Secondary outcomes (19)
Rate of seroconversion in contacts, defined as a positive IgG (immunoglobulineG) for monkeypox
To evaluate the rate of seroconversion in contacts (positive IgG for MPX) within 21 days after contact with index case
Measured: Until 21 days after contact with index case
Proportion of seroconversion in PCR positive contacts vs PCR negative contacts, defined as negative MPXV PCR in all samples until the end of the follow-up period
Proportion of seroconversion in PCR positive contacts vs PCR negative contacts, defined as negative MPXV PCR in all samples until the end of the follow-up period
Measured: Until 21 days after contact with index case
Time to seroconversion overall, in symptomatic and asymptomatic contacts, and in PCR positive and negative cases
Time to seroconversion overall, in symptomatic and asymptomatic contacts, and in PCR positive and negative cases
Measured: Until 21 days after contact with index case
Proportion of PCR positive participants with asymptomatic infection at time of first positive PCR
Proportion of PCR positive participants with asymptomatic infection at time of first positive PCR
Measured: Until 21 days after contact with index case
Proportion of PCR positive participants developing symptoms within the follow-up period
Proportion of PCR positive participants developing symptoms within the follow-up period
Measured: Until 21 days after contact with index case
Proportion of asymptomatic infections on number of contacts in follow-up. Asymptomatic infections are defined as contacts with positive MPXV PCR on any clinical sample, without development of any symptoms.
Proportion of asymptomatic infections on number of contacts in follow-up. Asymptomatic infections are defined as contacts with positive MPXV PCR on any clinical sample, without development of any symptoms within 3 weeks after exposure or within 1 week after PCR positivity, whichever follow-up is longer
Measured: within 3 weeks after exposure or within 1 week after PCR positivity, whichever follow-up is longer
Time from MPXV PCR positivity in any sample to appearance of any symptom overall and per mode of transmission (close personal contact; anal, vaginal or oral receptive sexual contact; and insertive sexual contact)
Time from MPXV PCR positivity in any sample to appearance of any symptom overall and per mode of transmission (close personal contact; anal, vaginal or oral receptive sexual contact; and insertive sexual contact)
Measured: at the end of the 3-week follow-up period
Time from MPXV PCR positivity in any sample to appearance of skin lesions
Time from MPXV PCR positivity in any sample to appearance of skin lesions
Measured: at the end of the 3-week follow-up period
Time from confirmed exposure to first PCR positivity
Time from confirmed exposure to first PCR positivity
Measured: at the end of the 3-week follow-up period
Time from confirmed exposure to appearance of any symptom
Time from confirmed exposure to appearance of any symptom
Measured: at the end of the 3-week follow-up period
Time from confirmed exposure to appearance of skin lesions
Time from confirmed exposure to appearance of skin lesions
Measured: at the end of the 3-week follow-up period
Description of the type of symptoms observed in monkeypox contacts
Description of the type of symptoms observed in monkeypox contacts within 3 weeks after last exposure
Measured: within 3 weeks after last exposure
Frequency of symptoms observed in monkeypox contacts
Frequency of symptoms observed in monkeypox contacts within 3 weeks after last exposure
Measured: within 3 weeks after last exposure
Timing of symptoms observed in monkeypox contacts
Timing of symptoms observed in monkeypox contacts within 3 weeks after last exposure
Measured: within 3 weeks after last exposure
Distribution of skin lesions for sexual contacts versus close personal contacts. (per body surface and per category: local vs generalized skin lesions)
Distribution of skin lesions for sexual contacts versus close personal contacts. (per body surface and per category: local vs generalized skin lesions)
Measured: at the end of the 3-week follow-up period
Proportion of contacts presenting with systemic symptoms after sexual exposure versus those with close personal contacts exposure
Proportion of contacts presenting with systemic symptoms after sexual exposure versus those with close personal contacts exposure
Measured: at the end of the 3-week follow-up period
Number of contacts with the defined risk and protective factors
Number of contacts with the defined risk and protective factors
Measured: At baseline
Proportion of presence of defined factors in PCR positive contacts.
Proportion of presence of defined factors in PCR positive contacts.
Measured: Until the end of the 3-week follow-up period
Proportion of presence of defined factors in symptomatic PCR positive contacts
Proportion of presence of defined factors in symptomatic PCR positive contacts
Measured: Until the end of the 3-week follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start22 Jun 2022
- Primary completion25 Aug 2022
- Study completion25 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Monkey PoxStudies of the same condition, open and under way.
- 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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurens Liesenborghs, MD, Principal investigator, Instituut van Tropische Geneeskunde Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05443867
- Sponsor's protocol ID
- MPX-Assess
- Acronym
- MPX-Assess
- Status last verified
- Sep 2023
- First submitted
- 21 Jun 2022
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 37212312
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monkeypox ASymptomatic Shedding: Evaluation by Self-Sampling MPX-ASSESS
- ClinicalTrials.gov ID
- NCT05443867
- Acronym / sponsor ID
- MPX-Assess / MPX-Assess
- Conditions
- Monkey Pox
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Institute of Tropical Medicine, BelgiumUniversity, hospital or other
- Study start
- 22 Jun 2022 (actual)
- Primary completion
- 25 Aug 2022 (actual)
- Study completion
- 25 Aug 2022 (actual)
- First posted
- 5 Jul 2022 (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 (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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MPX-Assess | – | –Contacts of MPX index cases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (11 listed)
- Be a high risk or very high-risk contact of a laboratory confirmed monkeypox case, with:
- Last exposure to the monkeypox index case of less than 21 days ago
- Adult participants (≥ 18 years old) of any gender
- Written informed consent is obtained from the participant
Key exclusion criteria (4 listed)
- Presenting with symptoms compatible with MPX:
- Inability or unwillingness to comply with the proposed follow-up schedule
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Secondary attack rate of MPXV infection in contacts, defined by PCR positivity on any sample
Time frame: Until 21 days after contact with index case
Secondary attack rate of MPXV infection in contacts, defined by PCR positivity on any sample
19 secondary outcomes
Rate of seroconversion in contacts, defined as a positive IgG (immunoglobulineG) for monkeypox
Time frame: Until 21 days after contact with index case
Proportion of seroconversion in PCR positive contacts vs PCR negative contacts, defined as negative MPXV PCR in all samples until the end of the follow-up period
Time frame: Until 21 days after contact with index case
Time to seroconversion overall, in symptomatic and asymptomatic contacts, and in PCR positive and negative cases
Time frame: Until 21 days after contact with index case
Proportion of PCR positive participants with asymptomatic infection at time of first positive PCR
Time frame: Until 21 days after contact with index case
Proportion of PCR positive participants developing symptoms within the follow-up period
Time frame: Until 21 days after contact with index case
Proportion of asymptomatic infections on number of contacts in follow-up. Asymptomatic infections are defined as contacts with positive MPXV PCR on any clinical sample, without development of any symptoms.
Time frame: within 3 weeks after exposure or within 1 week after PCR positivity, whichever follow-up is longer
Time from MPXV PCR positivity in any sample to appearance of any symptom overall and per mode of transmission (close personal contact; anal, vaginal or oral receptive sexual contact; and insertive sexual contact)
Time frame: at the end of the 3-week follow-up period
Time from MPXV PCR positivity in any sample to appearance of skin lesions
Time frame: at the end of the 3-week follow-up period
Time from confirmed exposure to first PCR positivity
Time frame: at the end of the 3-week follow-up period
Time from confirmed exposure to appearance of any symptom
Time frame: at the end of the 3-week follow-up period
Time from confirmed exposure to appearance of skin lesions
Time frame: at the end of the 3-week follow-up period
Description of the type of symptoms observed in monkeypox contacts
Time frame: within 3 weeks after last exposure
Frequency of symptoms observed in monkeypox contacts
Time frame: within 3 weeks after last exposure
Timing of symptoms observed in monkeypox contacts
Time frame: within 3 weeks after last exposure
Distribution of skin lesions for sexual contacts versus close personal contacts. (per body surface and per category: local vs generalized skin lesions)
Time frame: at the end of the 3-week follow-up period
Proportion of contacts presenting with systemic symptoms after sexual exposure versus those with close personal contacts exposure
Time frame: at the end of the 3-week follow-up period
Number of contacts with the defined risk and protective factors
Time frame: At baseline
Proportion of presence of defined factors in PCR positive contacts.
Time frame: Until the end of the 3-week follow-up period
Proportion of presence of defined factors in symptomatic PCR positive contacts
Time frame: Until the end of the 3-week follow-up period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Derived from this study: PubMed 37212312Brosius 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.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
Laurens Liesenborghs, MD principal investigator
Instituut van Tropische Geneeskunde Antwerpen
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 Monkey Pox, run by Institute of Tropical Medicine, Belgium at 1 site in Belgium.
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 11 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: finished, as of the sponsor's last update on 29 Sep 2023. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Secondary attack rate of MPXV infection in contacts, defined by PCR positivity on any sample (time frame: Until 21 days after contact with index case). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05443867, which also lists 1 linked publication.
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 29 Sep 2023.