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Mpox Prospective Observational Cohort Study

NCT06291259 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2024-03-04

No results posted yet for this study

Summary

The goal of this multicentre prospective observational cohort study is to shed light on the following unknowns:

1. The clinical manifestations of Mpox infection since the 2022 outbreak in Canada.
2. The social and psychological impacts of Mpox infection since the 2022 outbreak in Canada
3. The transmissibility of Mpox infection
4. Viral shedding over time in infected individuals

The study is divided into Part 1 (corresponding to the acute phase of illness) and Part 2 (corresponding to the convalescent phase of the illness); part 2 will be optional. Participants enrolled during the acute phase of illness will complete part 1 of the study and will be invited to participate in Part 2 as well. Part 1 of the study will include the following three core components, at baseline and weekly (±3 days) until one week after the resolution of all symptoms (i.e. one week after complete healing of skin lesions):

1. Collection of clinical data through chart review and research staff interviews with study participants
2. Participant self-administered online questionnaires at baseline and a thrice-weekly 'acute phase participant diary'
3. Specimen collection for Mpox-related testing Optional components for Part 1 include baseline-only, questionnaire-only, and frequent sampling.

Other optional components for all participants include in the Image Atlas, an online database of clinical images of mpox, designed to provide clinicians and community members of what mpox looks like in real life, and the biobank, which will store research samples for potential future studies.

Conditions

  • Monkeypox

Sponsors & Collaborators

  • Unity Health Toronto

    lead OTHER

Principal Investigators

  • Darrell HS Tan, MD · Unity Health Toronto

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-21
Primary Completion
2024-09-30
Completion
2024-09-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06291259 on ClinicalTrials.gov