monkey-pox
Conditions
Interventions
None listed
Sponsors
GGD Amsterdam
Eligibility
Age
16 Years to 99 Years
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 hospi | — |
Countries
Netherlands
Outcome results
None listed