Clinical characterisation of mpox (monkeypox) affecting people in Nigeria Infections and Infestations
Conditions
Interventions
Clinical and demographic data will be collected at recruitment and at follow-up visits, using a structured case report form. Where feasible, biological samples will be taken at recruitment and follow-
Sponsors
London School of Hygiene & Tropical Medicine
Eligibility
Sex/Gender
All
Age
0 Years to 120 Years
Inclusion criteria
Inclusion criteria: Case definitions are informed by NCDC case definitions for mpox but some may have been amended for recruitment to this study. See note at the end about preferred recruitment of confirmed cases only. 1. Confirmed case of mpox: a clinically compatible case where mpox infection has been confirmed by laboratory testing 2. Probable case of mpox: a clinically compatible case with epidemiological linkage but where laboratory confirmation of infection could not be obtained 3. Suspected case of classical mpox according to the extant NCDC case definition (current definition: a person with acute illness with fever >38.3°C, intense headache, lymphadenopathy, back pain, myalgia, and intense asthenia followed one to three days later by a progressively developing rash often beginning on the face (most dense) then spreading elsewhere on the body, including soles of feet and palms of hand) or suspected non-classical / atypical mpox based on a clinician’s assessment (e.g., absence of prodromal illness but mpox lesions are present, or mpox lesions with a more localised distribution, or predominantly genital/anorectal mpox lesions) Note: The recruitment of laboratory-confirmed cases is preferred over the recruitment of probable and suspected cases; however, probable and suspected cases may be recruited at the discretion and direction of the study’s central coordinating team if real-time laboratory diagnosis is not possible or proves to be too slow to facilitate timely recruitment of participants. If suspected cases are recruited, subsequent analyses of data will recognise the important differences between confirmed, probable, and suspected cases and, accordingly, separate analyses of a single sub-cohort (e.g., confirmed cases only, suspected cases only) or combined sub-cohorts (e.g., confirmed and probable cases) will be performed when necessary. If suspected cases are recruited, data from those participants where mpox is subsequently and confidently excluded by laboratory testing may provide a useful control group and/or reveal common alternative diagnoses in suspected mpox cases, which could help refine case definitions and clinical diagnostic guidance. However, the primary purpose of this study is to clinically characterise confirmed cases of mpox. A recruited suspected case may later become a confirmed case if laboratory testing is delayed; all sub-cohort analyses will use participants’ final mpox status based on data available at their outcome assessments.
Exclusion criteria
Exclusion criteria: 1. Confirmed diagnosis of a pathogen unrelated to the objectives of this study and there is no indication or likelihood of co-infection with MPXV 2. Mpox is not suspected clinically and there is no laboratory evidence of MPXV infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Common clinical haematology and biochemistry variables, including inflammatory markers and markers of end-organ abnormalities, in patients in the acute phase of mpox and, where longitudinal samples are available, analysis of changes in common haematology and biochemistry variables during illness. 2. Quantification of MPXV present in different samples using quantitative/semi-quantitative PCR and, where longitudinal samples are obtained, how these change over time and how the dynamics relate to the observed clinical course, severity of mpox and clinical outcomes. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Quantification of multiple soluble immune mediators (cytokines and chemokines) in blood and blood markers using high-sensitivity assays, including comparisons of levels in longitudinally obtained samples, to better understand the nature of the innate and adaptive responses to MPXV infection and how these may be associated with disease manifestations and outcomes. 2. Levels of anti-orthopox antibodies (IgM, IgG, total Ab, measured by ELISA) in response to natural infection over time and how these relate to differences in clinical courses and viral replication dynamics in infected individuals. 3. Quantification of anti-orthopox antibodies at baseline (recruitment) and how these relate to the subsequent, observed clinical course of mpox and the viral dynamics in the infected individuals. 4. Genetic sequencing of lesion-swab samples and blood samples containing viral DNA to look for within-host genetic changes in MPXV over time, whether this is influenced by non-viral factors such as host immunodeficiency states (e.g. severe immunosuppression) and/or drug-selection pressure (should anti-orthopox antivirals be administered as part of routine clinical care), and how any viral genetic changes detected relate to the observed course of the disease. 5. Comparison of sequences obtained from two different anatomical sites within an individual to see if these differ and whether they are associated with different patterns or severities of mpox disease at those different anatomical sites. 6. Variability of mpox virus clades and sub-clades within the study population, assessed by viral genome sequencing and bioinformatics, with cross-referencing of published sequences from previous and contemporary samples from mpox cases in Nigeria. | — |
Countries
Nigeria
Contacts
Public ContactChioma Achi
Outcome results
None listed