A One Health Study of Monkeypox Human Infection (AFRIPOX)

December 19, 2023 updated by: Institut Pasteur

A One Health Study of Monkeypox Human Infection, Animal Reservoir, Disease Ecology and Diagnostic Tools

This multidisciplinary project aim to understand the epidemiology of the monkeypox in Central African Republic through the identification of the animal reservoir, the clinical and epidemiological description of the human outbreak, through an ethnological approach around risk factors of the disease and through an ecological approach of the ecological context of emergence, and the improvement of biological diagnosis.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This project is composed by monkyepox disease outbreak investigation in the CAR following national surveillance framework.

Study Type

Observational

Enrollment (Estimated)

280

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The populations concerned by the study correspond to the sedentary populations known as "Bantus" and the more mobile populations known as "pygmies. These populations belong to different ethno-linguistic groups with more or less specific forest uses and subsistence practices: some are slash-and-burn farmers (Ngbaka, Bagando, Monzombo), others are more mobile and traditionally hunter-gatherers, but now practice agriculture (Bayaka "Pygmies").

Translated with www.DeepL.com/Translator (free version)

Description

Inclusion Criteria:

  • Human population in villages affected by monkeypox epidemics: patients who developed monkeypox and their contacts
  • Health care personnel (paramedics, nurses, doctors) who work or have worked in affected villages
  • Traditional healers, diviners
  • Members of villages affected by past monkeypox epidemics

Exclusion Criteria:

  • area not accessible to investigation
  • refusal to participate
  • inability to obtain consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Risk factors transmission cases
Human cases of monkeypox confirmed by PCR
Other: blood samples
5 mL
Other: Scabs and pus samples
if available
Risk factors transmission contacts and co-exposures
Human contact of confirmed monkeypox cases
Other: blood samples
5 mL
Serological follow up cases
Human cases of monkeypox confirmed by PCR from Lobaye region
Other: blood samples
5 mL
Other: Scabs and pus samples
if available
Serological follow up contacts and co-exposures
Human contact of confirmed monkeypox cases from Lobaye region adjusted for age, month of the year and village of origin
Other: blood samples
5 mL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of monkeypox cases occuring following interhuman exposures
Time Frame: 36 months
through a quantitative case-control study with an odds ratio of >3 for an exposure factor for human-to-human transmission.
36 months
Proportion of monkeypox cases occuring following zoonotic exposures
Time Frame: 36 months
through a quantitative case-control study with an odds ratio of >3 for an exposure factor for zoonotic transmission.
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of the Effective reproduction rate R in CAR according to the level of immunity (smallpox vaccine immunity or orthopoxvirus-related post disease immunity).
Time Frame: 36 months
measurement of the level of population natural immunity and post vaccinal immunity to determine the Effective reproduction rate R and changes in R between 2000-2020 according to the evolution of immunity (smallpox vaccine immunity or orthopoxvirus-related post disease immunity).
36 months
measurement of the sensitivity and the specificity of the existing diagnostic tests and those developed within the framework of the project
Time Frame: 36 months
sensitivity and specificity of the existing diagnostic tests and those developed within the framework of the project, as well as the reproducibility of measurements in relation to reference tests.
36 months
Identification and interpretation of genomic viral mutations from the viral sequences isolated from humans and animals in CAR for Phylogenetic and phylogeographic study of the monkeypox virus
Time Frame: 36 months
identification and interpretation of mutations, search for the common ancestor.
36 months
Comparison of genetic proximities between different viral strains isolated in humans and animals in CAR and neighboring countries since 1980.
Time Frame: 36 months
Comparison of genetic proximities
36 months
Identification of the characteristics associated with the environments in which human cases of monkeypox virus infection have occurred
Time Frame: 36 months
ecosystems and their recent modifications, land use, associated climatic/meteorological elements in the tropical zone (CAR, Northern DRC...).
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Pasteur

Collaborators

Institut Pasteur de Bangui

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2021

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

September 24, 2021

First Submitted That Met QC Criteria

September 27, 2021

First Posted (Actual)

September 28, 2021

Study Record Updates

Last Update Posted (Actual)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 19, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-047

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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