Mpox Prospective Observational Cohort Study

Status: Recruiting
Location: See all (3) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

⁃ Part 1:

⁃ • Being investigated for Mpox infection by a clinician based on clinical (i.e. symptoms) and/or epidemiologic (i.e. exposure to confirmed case) grounds;

⁃ Part 2:

• Clinically confirmed to be in the convalescent phase (i.e. confirmed for Mpox infection previously)

• Within 12 weeks of symptom onset

Locations
Other Locations
Canada
Unity Health Toronto
RECRUITING
Toronto
University Health Network
RECRUITING
Toronto
BC Centre For Excellence
RECRUITING
Vancouver
Contact Information
Primary
Abby Li
abby.li@unityhealth.to
416-360-4000
Time Frame
Start Date: 2022-06-21
Estimated Completion Date: 2024-09
Participants
Target number of participants: 250
Treatments
Confirmed positive for mpox
Participants with laboratory test results confirming the diagnosis of Mpox. This includes the total number of unique participants who complete the main part 1 study, those who complete the baseline visit only, those who agree to frequent sampling, and those who only participate in part 2.
Confirmed negative for mpox
Participants in whom the clinician feels that the diagnosis of Mpox has been clearly ruled out.
Related Therapeutic Areas
Sponsors
Leads: Unity Health Toronto

This content was sourced from clinicaltrials.gov