Mpox Prospective Observational Cohort Study

NCT06291259 | Recruiting

• 1 other identifier: CTO 4081
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 3

Brief Summary

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

1. 1.The clinical manifestations of Mpox infection since the 2022 outbreak in Canada.
2. 2.The social and psychological impacts of Mpox infection since the 2022 outbreak in Canada
3. 3.The transmissibility of Mpox infection
4. 4.Viral shedding over time in infected individuals
5. 5.Collection of clinical data through chart review and research staff interviews with study participants
6. 6.Participant self-administered online questionnaires at baseline and a thrice-weekly 'acute phase participant diary'
7. 7.Specimen collection for Mpox-related testing Optional components for Part 1 include baseline-only, questionnaire-only, and frequent sampling.

Conditions

Monkeypox

Keywords

mpox

Outcome Measures

Primary Outcomes (4)

• Description of clinical manifestation

  Clinical manifestations of mpox infection during the Canadian outbreak, including symptom duration and spectrum, complications, natural history and sources of variability in clinical manifestations

  12 weeks

• Psychosocial impact

  Describe the psychosocial impacts of mpox-related illness and isolation requirements, including financial insecurity, psychological distress and perceived and enacted stigma

  12 weeks

• Transmission-related aspects of mpox infection

  Types and timing of human and animal contacts prior to mpox infection, as well as quantifying the detectability of mpox viral DNA in the immediate environment of people ultimately diagnosed with the infection, including physical surfaces and air samples

  12 weeks

• Virologic aspects of mpox infection over time

  Detectability of mpox viral DNA by polymerase chain reaction (PCR) along with the associated cycle threshold, as well as titers of infectious virus, in different anatomic compartments and examining the viral genomic sequence. Outcomes also include characterizing the host response to mpox infection including host gene and cytokine expression and antibody titers.

  12 weeks

Study Arms (2)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Our overarching goal is to characterize key clinical and epidemiologic aspects of Mpox infection in Canada in the context of the rapidly emerging outbreak. As such we will deliberately include people both with (n=250) and without (number to be determined based on accrual of confirmed cases) the condition of interest because it is important to have a comparison group of people who are ultimately confirmed not to have the infection

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (3)

BC Centre For Excellence

Vancouver, British Columbia, V6Z 1Y6, Canada

RECRUITING

Unity Health Toronto

Toronto, Ontario, M5B 1T8, Canada

RECRUITING

University Health Network

Toronto, Ontario, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Acute phase: 1. Blood 2. Urine 3. Nasopharyngeal swab 4. Throat swab 5. Rectal swab 6. Semen sample or vaginal swab, as applicable 7. Skin lesions (see below) 8. Breastmilk, if lactating Convalescent phase: 1. Rectal swab 2. Semen sample/vaginal swab (as applicable) 3. Breastmilk (if applicable). Samples are collected for testing of mpox PCR and serology. Participants will be asked to consent to storage of these samples for future testing as well (e.g. biobanking)

MeSH Terms

Conditions

Mpox, Monkeypox

Condition Hierarchy (Ancestors)

Poxviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Primate Diseases; Animal Diseases; Rodent Diseases

Study Officials

• Darrell HS Tan, MD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abby Li

CONTACT

416-360-4000; abby.li@unityhealth.to

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 4, 2024
• Study Start: June 21, 2022
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: March 4, 2024

Record last verified: 2024-02

Locations

CA (3)