NCT05476744

Brief Summary

The present observational study has been designed to understand the dynamics of viral clearance amongst patients with confirmed monkeypox, by quantifying monkeypox viral load in different specimens trough time, to better inform decision-making about patient management and isolation guidelines. Also, an immune analysis will be performed in a subset of individuals to describe humoral and cellular responses to monkeypox.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2022

Shorter than P25 for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 28, 2022

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

July 21, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 27, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2023

Completed
Last Updated

September 18, 2023

Status Verified

September 1, 2023

Enrollment Period

3 months

First QC Date

July 21, 2022

Last Update Submit

September 15, 2023

Conditions

Monkeypox

Keywords

MonkeypoxViral clearanceViral dynamics

Outcome Measures

Primary Outcomes (6)

  • Viral clearance in skin lesions

    Time to undetectable monkeypox viral load in skin lesions (Number of days)

    From day 1 to day 57

  • Viral clearance in blood

    Time to undetectable monkeypox viral load in blood (Number of days)

    From day 1 to day 57

  • Viral clearance in oropharyngeal swabs

    Time to undetectable monkeypox viral load (Ct) in oropharyngeal swabs (Number of days)

    From day 1 to day 57

  • Viral clearance in rectum swabs

    Time to undetectable monkeypox viral load (Ct) in rectum swabs (Number of days)

    From day 1 to day 57

  • Viral clearance in semen discharge

    Time to undetectable monkeypox viral load in semen (Number of days)

    From day 1 to day 57

  • Viral clearance in vaginal discharge

    Time to undetectable monkeypox viral load in vaginal discharge (Number of days)

    From day 1 to day 57

Secondary Outcomes (2)

  • Humoral responses against monkeypox

    At baseline and 1, 3, and 6 months later

  • Cellular responses against monkeypox

    At baseline and 1, 3, and 6 months later

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult male and female patients with monkeypox infection.

You may qualify if:

  • Adult male or female individuals of ≥18 years old.
  • Examined by a specialist in sexually transmitted infections (STIs) and found to have lesions suggestive of monkeypox.
  • Symptomatic with symptoms onset date ≤10 days prior to screening/baseline visit.
  • Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the trial.
  • Has understood the information provided and capable of giving informed consent.

You may not qualify if:

  • Severe disease - defined as requires admission to hospital
  • Inability to consent and/or comply with trial protocol
  • An alternative confirmed diagnosis that can fully explain the illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Atenció Primària Metropolitana Nord

Sabadell, Barcelona, 08204, Spain

Location

Drassanes Vall d'Hebron Centre for International Health and Infectious diseases

Barcelona, 08001, Spain

Location

BCN Checkpoint

Barcelona, 08015, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

Skin lesions, blood, throat, rectum, semen, and vaginal fluid.

MeSH Terms

Conditions

Mpox, Monkeypox

Condition Hierarchy (Ancestors)

Poxviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsPrimate DiseasesAnimal DiseasesRodent Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Infectious Diseases and Global Heaelth

Study Record Dates

First Submitted

July 21, 2022

First Posted

July 27, 2022

Study Start

June 28, 2022

Primary Completion

September 22, 2022

Study Completion

March 30, 2023

Last Updated

September 18, 2023

Record last verified: 2023-09

Locations

ES(5)