B04
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Age = 18 years, Willingness to participate in the study, Symptomatic MPV infection (e.g. rash, fever, or other signs and symptoms associated with MPV infection and without other more plausible cause), Consent within 14 days of symptom onset, Positive MPV PCR from blood or skin sample (swab or biopsy)
Exclusion criteria
Exclusion criteria: Any condition that prohibits supplemental blood-sampling beyond routine blood drawing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Following the principle of NAPKON as a data and biospecimen collection platform for the Netzwerk Universitätsmedizin NUM, a specific primary endpoint was not included. The primary objective of the NAPKON Monkeypox Platform is to provide a comprehensive and harmonized collection of data and biosamples for researchers from national consortia and for participation in international research collaborations for the purpose of studying MPV Infection. | — |
Secondary
| Measure | Time frame |
|---|---|
| We specifically aim at generating hypotheses regarding: - Infection with MPV and its primary and secondary pathophysiologic changes of various organ systems and of the immune system - Association of severe disease course with organ failure - Modulation of innate immune system - Specific activation of the adaptive immune system - Analysis of MPV induced immune response and its change over time to identify biomarkers and develop therapeutic strategies - Detailed analysis of MPV induced adaptive (humoral and cellular) immune response to support the development of vaccines - Identification of inflammatory biomarkers for early estimation of disease progression and choice of therapeutic option - Combination of microbiologic and immunologic analyses to provide information on the role of bacterial superinfection in the pathophysiology of MPV - Analysis of viral and bacterial diversity, viral load to provide prognostic biomarkers for disease progression and infectiousness - Single cell multiomics analysis of patient material to provide insights into MPV infection to identify therapeutic targets - Integrative analysis of clinical parameters with molecular results to provide insight into MPV infection as well as the variability of the disease course, including possible predictors of health sequelae - Determine risk-factors, define clinical course of disease and investigate long-term sequelae in smallpox vaccine breakthrough infections - Epigenetic factors and impact on the clinical course of MPV infectio | — |
Countries
Germany