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…
ID
Source
Brief title
Condition
- Viral infectious disorders
- Skin and subcutaneous tissue disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Objective
1: What is the time to resolution of symptoms among patients with symptomatic
MPXVID?
Outcome measure
1: 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.
Secondary outcome
Secondary objectives and outcome measures
Objectives
2: To describe and analyse demographic, sexual and other clinical
characteristics in patients with MPXVID.
3: To describe virological outcomes in patients with MPXVID.
4: To describe changes in sexual behaviour and psychosocial outcomes in
patients with MPXVID in comparison to controls.
5: To estimate the effectiveness against MPXVID of infant smallpox vaccine
given before 1974.
6: To estimate the effectiveness against MPXVID of modified vaccinia Ankara
(MVA) smallpox vaccine.
7: To describe the use of antiviral medication and/or immunoglobulins.
Outcome measures
2: Other clinical outcomes on days 4, 8, 14, 21, 28, 60 and 180, as follows:
• Clinical status of MPXVID at baseline and days 4, 8, 14, 21, 28, 60 and 180
according to a four-point ordinal scale (all lesions resolved and no serious
complications* of MPXVID, active lesions and no serious complications* of
MPXVID, hospitalised because of a serious complication* of MPXVID, and death).
• 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 DLQI with outcome above 10 points)
• Proportion of patients with secondary bacterial infection of MPXVID lesions
• Proportion of patients with scars at day 180 (measured with Vancouver scar
scale).
• Demographic, sexual and clinical risk factors for MPXVID
• Co-infection(s) with sexual transmitted infections (i.e., chlamydia,
gonorrhoea, HIV, syphilis, viraemic or chronic Hepatitis B infection, and
vireamic or past Hepatitis C infection)
* Definition of a serious complication: a case that is life-threatening or that
results in hospitalisation or prolongation of existing hospitalisation, or
results in a disability or incapacity, or results in any other complication
that is considered medically significant.
3: Virological status defined by:
• Presence of MPXV DNA and cycle threshold (Ct) values in lesion swabs on
baseline and days 4, 8, 14, 21 and 28.
• Change from baseline in MPXV DNA levels in anal-, pharyngeal and vaginal
swabs on days 4, 8, 14, 21, 28, 60 and 180.
• Change from baseline in MPXV DNA levels in blood on days 4, 8, 14, 21, 28,
60, and 180.
• Change from baseline in MPXV DNA levels in semen on days 4, 8, 14, 21, 28, 60
and 180.
4: To describe changes in sexual behaviour and psychosocial outcomes in
patients with MPXVID in comparison to controls:
• DLQI questionnaire measurement of the quality of life change at baseline and
change at days 14, 28, 60 and 180 (only baseline and day 180 for controls).
• SFQ questionnaire measurement of fatigue at baseline and change at days 14,
28, 60 and 180 (only baseline and day 180 for controls).
• PHQ-SADS questionnaire measurement of anxiety, depression, somatic complaints
at baseline and change at days 14, 28, 60 and 180 (only baseline and day 180
for controls).
• Questionnaires of the experience of (internalized) stigma at baseline and
change at days 14, 28, 60 (only baseline and day 180 for controls).
• Sexual behaviour measurement at baseline and change at days 14, 28, 60 and
180 (only baseline and day 180 for controls).
5: Measuring the proportion of patients with a laboratory confirmed monkeypox
virus disease and of controls without MPXVID who are vaccinated with the infant
smallpox vaccine before 1974, and estimate vaccine effectiveness (i.e. disease
severity outcome).
6: Measuring the proportion of patients with a laboratory confirmed monkeypox
virus disease and of controls without MPXVID who are vaccinated with the MVA
smallpox vaccine, either as pre- or as post-exposure prophylaxis against MPX
after June 2022.
7: Measuring the proportion of patients treated with antiviral and/or
immunoglobulins.
Background 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. 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 4000 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 GBMSM (gay, bisexual and other men who have
sex with men). There is an urgent need to address essential knowledge gaps for
optimal clinical care and public health management.
Study objective
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, we will also include a control population of men
without proctitis and MPXVID-related symptoms at day 0. In addition, we 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 MPXVID patients.
Study design
This study is designed as a prospective observational cohort study in patients
with laboratory confirmed MPXVID compared with controls without proctitis and
without MPXVID-related symptoms. However, patients who are being managed as a
presumptive case can also be enrolled while laboratory confirmation is pending.
We will also include controls without proctitis and without MPXVID-related
symptoms who will only have a study visit at baseline (day 0), and day 60 and
180. A participant who is a presumptive case and subsequently tests negative
for MPXV will be asked to be included as a control.
Study burden and risks
Participation in the study lasts a maximum of 180 days (6 months) from the
first day of admission. Participation for cases requires 8 study visits and for
controls 3. Burden: the time people spend to come to the GGD and physical
burden: extra blood and swabs taken. The collection of blood and swabs belong
to standard procedures of the sexual health center.
Nieuwe Achtergracht 100
Amsterdam 1018WT
NL
Nieuwe Achtergracht 100
Amsterdam 1018WT
NL
Listed location countries
Age
Inclusion criteria
For cases
I. Laboratory confirmed MPXVID, or
II. A presumptive MPXVID case with pending laboratory confirmation
For controls
• Individuals without proctitis and MPXVID-related symptoms
Exclusion criteria
For cases:
• Presumptive cases with subsequent negative test for MPXV (can subsequently 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;
• Living in long term care facility.
For controls:
• 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL82230.018.22 |