MonkeypoxProMPXNCT05567939
Clinical, Virological, Immunological, Psychosocial and Epidemiological Consequences of Human Monkeypox Virus (ProMPX)
An observational study of Monkeypox and Monkey Pox, run by Public Health Service of Amsterdam at 1 site in Netherlands.
Trial summary
MonkeyPox Virus Infectious Disease (MPXVID) is a viral infection caused by the monkeypox virus (MPXV) which is an orthopoxvirus that is endemic in countries in West and Central Africa. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Monkeypox, Monkey Pox
- What is being tested?
- Natural course of disease
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- 19 Sep 2022to 31 Dec 2023
- How long will I take part?
- 6 Months
- 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 16 years and older
- All sexes
- Child, Adult, Older adult
Study population: The target population are all individuals visiting the STI-clinic of the Public Health Services of Amsterdam, irrespective of their gender, aged 16 years or older with a laboratory confirmed MPXV infection, or are suspected of MPXV while laboratory confirmation is pending. MPXV infection is diagnosed according to a routinely performed PCR test on lesion, anal-, pharyngeal and vaginal swabs in patients suspect of having MPXVID. The controls will be clients of the STI clinic who are individuals without proctitis and without MPXVID-related symptoms; they will only be matched on date of inclusion.
Who may be able to join
- Case:
- Individuals, with: I. Laboratory confirmed MPXVID, or II. A presumptive MPXVID case with pending laboratory confirmation
- Be able to provide informed consent by means of: I. Verbal or deferred informed consent, which will be complemented with a written informed consent during the subsequent outpatient study visit; II. Written informed consent during the baseline visit for presumptive cases
- Sufficient understanding of the Dutch or English language.
- Control:
- Individuals without proctitis and MPXVID-related symptoms
Who cannot join
- Case:
- Presumptive cases with subsequent negative test for MPXV (can be included as control);
- Being under the age of 16 years old;
- Unlikely to comply with the study procedures, as deemed by the recruiting research doctor/nurse;
- Mental disorder that in the view of the investigator would interfere with adherence to the study procedures, or the decision to participate in the study;
- Investigators or otherwise dependent persons;
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- Living in long term care facility.
- Control:
- Positive test result for MPXV at baseline (day 0)
- Being under the age of 16 years old;
- Unlikely to comply with the study procedures, as deemed by the recruiting research doctor/nurse;
- Mental disorder that in the view of the investigator would interfere with adherence to the study procedures, or the decision to participate in the study;
- Investigators or otherwise dependent persons;
- Living in long term care facility.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical, Virological, Serological and Psychosocial Outcomes in Human Monkeypox Virus Infectious Disease - a PROspective Observational Cohort Study for Epidemiology and Outcomes of MPXVID
MonkeyPox Virus Infectious Disease (MPXVID) is a viral infection caused by the monkeypox virus (MPXV) which is an orthopoxvirus that is endemic in countries in West and Central Africa. The clinical course of the MPXVID is similar to smallpox (variola) but usually milder - with less severe disease symptoms seen in the West African subtype. Historically, the case fatality ratio of MPXVID ranged from 0 to 11% and fatality occurs more commonly among children. In Europe, human MPXVID only occurred as an imported disease with limited onward transmission. However, since May 2022 over 19.000 cases of MPXVID - mostly with the West African subtype - have been reported in Europe without a travel history to the endemic areas in Africa. The far large majority of patients with MPXVID in the current outbreak are gay, bisexual and other men who have sex with men (GBMSM). There is an urgent need to address essential knowledge gaps for optimal clinical care and public health management.
The aim of this study is to improve our understanding of clinical, virological, and psychosocial outcomes in patients with MPXVID. To get a better understanding of associated risk factors for MPXV infection, and to measure quality of life and stigma, the investigators will also include a control population of men without proctitis and MPXVID-related symptoms at day 0. In addition, the investigators want to assess the vaccine effectiveness against MPXVID of infant smallpox vaccination given before 1974, as well as vaccine effectiveness of the modified vaccinia Ankara (MVA) smallpox vaccine, when administered as pre- or post-exposure prophylaxis in high risk contacts of MPXVD patients.
- Conditions
- Monkeypox, Monkey Pox
- Being tested
- Natural course of disease
- Medical subject headings
- Mpox, Monkeypox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natural course of diseaseOther
Sample and questionnaire collection
| Study group | Role | What they receive |
|---|---|---|
| Case | Individuals with laboratory confirmed MPXVID Receives: Other: Natural course of disease | |
| Control | Individuals without proctitis and without MPXVID-related symptoms Receives: Other: Natural course of disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
What is the time to resolution of symptoms among patients with symptomatic MPXVID?
The time between appearance of the first lesions and the day on which all skin lesions are epithelialized and crusts fall off, and all systemic symptoms (incl. proctitis) have resolved.
Measured: 28 days
Secondary outcomes (14)
To describe and analyse demographic characteristics in patients with MPXVID.
Demographic characteristics at enrolment visit.
Measured: 180 days
To describe and analyse sexual characteristics in patients with MPXVID.
Sexual characteristics at enrolment visit.
Measured: 180 days
To describe and analyse clinical characteristics in patients with MPXVID.
Clinical status of MPXVID at baseline and days 4, 8, 14, 21, 60 and 180:
- According to a 4 pt ordinal scale.
- Location(s) of lesion(s): peri-genital, peri-anal, peri-oral, romp, arms, legs, head.
- Number of lesions: 1, 2-5, >5.
- Presence of proctitis related symptoms.
Measured: 180 days
To describe and analyse other clinical characteristics in patients with MPXVID.
Other clinical outcomes on days 4, 8, 14, 21, 60 and 180, as follows:
- Proportion of patients with systemic symptoms.
- Proportion of patients with proctitis.
- Proportion of patients with oral lesions, pharyngitis and/or oesophagitis
- Proportion of patients requiring pain medication.
- Proportion of patients requiring additional medical consultations
- Proportion of patients with a significant reduction of their quality of live (measured with Dermatology Life Quality Index (DLQI) with outcome above 10 points).
- Proportion of patients with secondary bacterial infection of MPXVID lesions.
Measured: 180 days
To describe the presence of MPXV DNA and cycle threshold (Ct) values in patients with MPXVID.
The presence of MPXV DNA and cycle threshold (Ct) values in lesion swabs on baseline and days 4, 8, 14, 21 and 28.
Measured: 180 days
To describe other virological outcomes in patients with MPXVID.
Change from baseline in MPXV DNA levels in anal-, pharyngeal and vaginal swabs, semen and blood (also the development of antibody levels) on days 4, 8, 14, 21, 28, 60 and 180.
Measured: 180 days
To describe changes in sexual behaviour in patients with MPXVID in comparison to controls.
Sexual behaviour measurement at baseline and change at days 14, 28, 60 and 180 (only baseline, day 60 and day 180 for controls).
Measured: 180 days
To describe changes in quality of life in patients with MPXVID in comparison to controls.
DLQI questionnaire measurement of the quality of live change at baseline and change at days 14, 28, 60 and 180 (only baseline, day 60 and day 180 for controls).
Measured: 180 days
To describe changes in the experience of (internalized) stigma in patients with MPXVID in comparison to controls.
Questionnaires of the experience of (internalized) stigma at baseline and change at days 28 and 180 (only baseline and day 180 for controls).
Measured: 180 days
To describe changes in the experience of fatigue in patients with MPXVID in comparison to controls.
Sexual Function Questionnaire (SFQ) questionnaire measurement of fatigue at baseline and change at days 14, 28, and 60 (only baseline and day 60 for controls).
Measured: 60 days
To describe changes in the physical and psychological health in patients with MPXVID in comparison to controls.
PATIENT HEALTH QUESTIONNAIRE - Schedule for Affective Disorders and Schizophrenia (PHQ-SADS) questionnaire measurement of anxiety, depression, somatic complaints at baseline and change at days 28 and 180 (only baseline and day 180 for controls).
Measured: 180 days
To estimate the effectiveness against MPXVID of infant smallpox vaccine given before 1974.
Measuring the proportion of patients with a laboratory confirmed MPXVID and of controls without MPXVID who are vaccinated with the infant smallpox vaccine before 1974, and estimate vaccine effectiveness (i.e. disease severity outcome).
Measured: through study completion, an average of 1 year
To estimate the effectiveness against MPXVID of modified vaccinia Ankara (MVA) smallpox vaccine.
Measuring the proportion of patients with a laboratory confirmed MPXVID and of controls without MPXVID who are vaccinated with the modified vaccinia Ankara (MVA) smallpox vaccine, either as pre- or as post-exposure prophylaxis against MPX after June 2022.
Measured: through study completion, an average of 1 year
To describe the use of antiviral medication and/or immunoglobulins.
Proportion of patients treated with antiviral and/or immunoglobulins.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start19 Sep 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Why it stopped: Due to the decrease in the number of mpox infections in the Netherlands, we were unable to include the desired number of study participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MonkeypoxStudies 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
- 12 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Public Health Service of Amsterdam
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Henry J.C. de Vries, Public Health Service of Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05567939
- Sponsor's protocol ID
- ProMPX
- Acronym
- ProMPX
- Status last verified
- May 2024
- First submitted
- 27 Sep 2022
- Last updated
- 3 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Virological, Serological and Psychosocial Outcomes in Human Monkeypox Virus Infectious Disease - a PROspective Observational Cohort Study for Epidemiology and Outcomes of MPXVID
- ClinicalTrials.gov ID
- NCT05567939
- Acronym / sponsor ID
- ProMPX / ProMPX
- Conditions
- Monkeypox, Monkey Pox
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to the decrease in the number of mpox infections in the Netherlands, we were unable to include the desired number of study participants.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Public Health Service of AmsterdamOther government
- Study start
- 19 Sep 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 5 Oct 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 Virus Infectious Disease (MPXVID) is a viral infection caused by the monkeypox virus (MPXV) which is an orthopoxvirus that is endemic in countries in West and Central Africa. The clinical course of the MPXVID is similar to smallpox (variola) but usually milder - with less severe disease symptoms seen in the West African subtype. Historically, the case fatality ratio of MPXVID ranged from 0 to 11% and fatality occurs more commonly among children. In Europe, human MPXVID only occurred as an imported disease with limited onward transmission. However, since May 2022 over 19.000 cases of MPXVID - mostly with the West African subtype - have been reported in Europe without a travel history to the endemic areas in Africa. The far large majority of patients with MPXVID in the current outbreak are gay, bisexual and other men who have sex with men (GBMSM). There is an urgent need to address essential knowledge gaps for optimal clinical care and public health management.
The aim of this study is to improve our understanding of clinical, virological, and psychosocial outcomes in patients with MPXVID. To get a better understanding of associated risk factors for MPXV infection, and to measure quality of life and stigma, the investigators will also include a control population of men without proctitis and MPXVID-related symptoms at day 0. In addition, the investigators want to assess the vaccine effectiveness against MPXVID of infant smallpox vaccination given before 1974, as well as vaccine effectiveness of the modified vaccinia Ankara (MVA) smallpox vaccine, when administered as pre- or post-exposure prophylaxis in high risk contacts of MPXVD patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Other: Natural course of diseaseIndividuals with laboratory confirmed MPXVID |
| Control | – | Other: Natural course of diseaseIndividuals without proctitis and without MPXVID-related symptoms |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The target population are all individuals visiting the STI-clinic of the Public Health Services of Amsterdam, irrespective of their gender, aged 16 years or older with a laboratory confirmed MPXV infection, or are suspected of MPXV while laboratory confirmation is pending. MPXV infection is diagnosed according to a routinely performed PCR test on lesion, anal-, pharyngeal and vaginal swabs in patients suspect of having MPXVID. The controls will be clients of the STI clinic who are individuals without proctitis and without MPXVID-related symptoms; they will only be matched on date of inclusion.
Key inclusion criteria (6 listed)
- Individuals, with: I. Laboratory confirmed MPXVID, or II. A presumptive MPXVID case with pending laboratory confirmation
- Be able to provide informed consent by means of: I. Verbal or deferred informed consent, which will be complemented with a written informed consent during the subsequent outpatient study visit; II. Written informed consent during the baseline visit for presumptive cases
- Sufficient understanding of the Dutch or English language.
- Individuals without proctitis and MPXVID-related symptoms
Key exclusion criteria (14 listed)
- Presumptive cases with subsequent negative test for MPXV (can be included as control);
- Being under the age of 16 years old;
- Unlikely to comply with the study procedures, as deemed by the recruiting research doctor/nurse;
- Mental disorder that in the view of the investigator would interfere with adherence to the study procedures, or the decision to participate in the study;
- Investigators or otherwise dependent persons;
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 |
|---|---|---|
| Natural course of diseaseSample and questionnaire collection | Other | Case, Control |
Primary outcome
What is the time to resolution of symptoms among patients with symptomatic MPXVID?
Time frame: 28 days
The time between appearance of the first lesions and the day on which all skin lesions are epithelialized and crusts fall off, and all systemic symptoms (incl. proctitis) have resolved.
14 secondary outcomes
To describe and analyse demographic characteristics in patients with MPXVID.
Time frame: 180 days
To describe and analyse sexual characteristics in patients with MPXVID.
Time frame: 180 days
To describe and analyse clinical characteristics in patients with MPXVID.
Time frame: 180 days
To describe and analyse other clinical characteristics in patients with MPXVID.
Time frame: 180 days
To describe the presence of MPXV DNA and cycle threshold (Ct) values in patients with MPXVID.
Time frame: 180 days
To describe other virological outcomes in patients with MPXVID.
Time frame: 180 days
To describe changes in sexual behaviour in patients with MPXVID in comparison to controls.
Time frame: 180 days
To describe changes in quality of life in patients with MPXVID in comparison to controls.
Time frame: 180 days
To describe changes in the experience of (internalized) stigma in patients with MPXVID in comparison to controls.
Time frame: 180 days
To describe changes in the experience of fatigue in patients with MPXVID in comparison to controls.
Time frame: 60 days
To describe changes in the physical and psychological health in patients with MPXVID in comparison to controls.
Time frame: 180 days
To estimate the effectiveness against MPXVID of infant smallpox vaccine given before 1974.
Time frame: through study completion, an average of 1 year
To estimate the effectiveness against MPXVID of modified vaccinia Ankara (MVA) smallpox vaccine.
Time frame: through study completion, an average of 1 year
To describe the use of antiviral medication and/or immunoglobulins.
Time frame: 180 days
Results and safety
The study was stopped early (reason given: Due to the decrease in the number of mpox infections in the Netherlands, we were unable to include the desired number of study participants.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Monkeypox and Monkey Pox, run by Public Health Service of Amsterdam at 1 site in Netherlands.
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 6 inclusion and 14 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: stopped early, as of the sponsor's last update on 3 Jun 2024. 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 Netherlands. 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 was stopped early (reason given: Due to the decrease in the number of mpox infections in the Netherlands, we were unable to include the desired number of study participants.). Results are not available in the source record.
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?
What is the time to resolution of symptoms among patients with symptomatic MPXVID? (time frame: 28 days). 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 3 Jun 2024.