Looking for Asymptomatic Mpox in a Population at High Risk | NCT06353737

Studies
Looking for Asymptomatic Mpox in a Population at High Risk

NCT06353737

Sponsor

Unity Health Toronto

Status

Unknown status

Last Update Posted

Apr 18, 2024Actual

Enrollment

450Estimated

Phase

Not provided

Conditions

Mpox (Monkeypox)

Interventions

Not provided

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2024Actual

Primary Completion Date

Mar 31, 2026Estimated

Completion Date

Mar 31, 2026Estimated

First Submitted Date

Apr 2, 2024

First Submission Date that Met QC Criteria

Apr 2, 2024

First Posted Date

Apr 9, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2024

Last Update Posted Date

Apr 18, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Mpox is caused by a virus that can be spread through touching the affected skin of someone who has the infection, touching sheets or clothes that has been used by someone with the infection, or breathing in particles of virus from someone who has the infection. Mpox infection can cause skin and flu-like symptoms, but can also cause very few symptoms, or no symptoms at all. While the number of participants with mpox symptoms can be tracked, little is known about how many people have mpox, but experience few or no symptoms at all. To do this, a Canadian sample of gay, bisexual and other men who have sex with men (GBMSM) who are participating in a randomized controlled trial will be screened for mpox symptoms. Screening will include questions about whether they may be experiencing any mpox symptoms, history of past diagnosis of mpox, sexual history, and vaccination history and awareness. Swabs will be taken to test for the presence of mpox virus, and a blood sample will be taken to test for antibodies. Approximately 450 individuals will be recruited. The results will be descriptive in nature.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

450Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Asymptomatic prevalence	To determine the prevalence of asymptomatic, pre-symptomatic and paucisymptomatic mpox infection (pooled and individually), in a population of GBMSM with anticipated high mpox risk and high prevalence of vaccination.	2 weeks

Secondary Outcomes

Measure	Description	Time Frame
Symptomatic prevalence	To determine the prevalence of symptomatic mpox infection in the study sample	2 weeks
Mpox seropositivity	To determine the prevalence of mpox seropositivity (both for total antibody and for neutralizing antibody) in the study sample

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

- Participants need to have been enrolled in an existing randomized clinical trial (NCT04762134)

Exclusion criteria:

- None

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Gay, bisexual, and other men who have sex with men

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Participants need to have been enrolled in an existing randomized clinical trial (NCT04762134)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Abby Li, MSc	Contact	416-360-4000	77426	abby.li@unityhealth.to

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Unity Health Toronto	Recruiting	Toronto	Ontario	M5B 1T8	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

Group level data will be made available upon request

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D045908	Mpox, Monkeypox

Ancestor Terms

ID	Term
D011213	Poxviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided