Recruiting

Observational Study

Sponsor:

Unity Health Toronto

Code:

NCT06291259

Conditions

Monkeypox

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Study Details

Brief 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

Study ID

NCT06291259

Start date

Jun 21, 2022

Status verified date

Feb, 2024

Completion date

Sep, 2024

Anticipated

Primary completion date

Sep, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria

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

Exclusion Criteria

• None

Study Design

Enrollment

250 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Description of clinical manifestation [ Time Frame: 12 weeks ]
  • Psychosocial impact [ Time Frame: 12 weeks ]
  • Transmission-related aspects of mpox infection [ Time Frame: 12 weeks ]
  • Virologic aspects of mpox infection over time [ Time Frame: 12 weeks ]

Central Contacts and Locations

Locations

BC Centre For Excellence

Recruiting

Vancouver, British Columbia, Canada, V6Z 1Y6

Contacts

Principal Investigator:

Mark Hull, MD

Unity Health Toronto

Recruiting

Toronto, Ontario, Canada, M5B 1T8

Contacts

Principal Investigator:

Darrell HS Tan

University Health Network

Recruiting

Toronto, Ontario, Canada

Contacts

Principal Investigator:

Sharon Walmsley, MD

More Information

Sponsor

Unity Health Toronto

Last update posted

Mar 4, 2024

Last verified

Feb, 2024

Keywords

  • mpox

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2024-03-04.