Mpox Biology, Outcome, Transmission and Epidemiology

NCT06652646 | Enrolling By Invitation DMC

• 1 other identifier: Project 427100 MPX
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The MBOTE-Kamituga clinical and virological characterization protocol is a prospective observational cohort study with clinical and virological description of suspected mpox cases and longitudinal follow-up of confirmed mpox cases. Research activities will be aligned as far as possible with the response to the epidemic.

Conditions

Mpox (Monkeypox)

Outcome Measures

Primary Outcomes (7)

• Characterize the clinical presentation of suspected mpox cases

  Viral Shedding Sites and Sampling Strategy: Identification of appropriate sites for viral shedding, presented as the number and types of body sites where viral shedding is detected. (qualitative measure) Proportion of Patients with VMPX-PCR Positivity by Sample Type: Proportion (%) of patients with VMPX-PCR positivity in each sample type (Skin swab, oropharyngeal swab, saliva, urine, semen, breast milk, anal swab, vaginal swab). MPXV-PCR Ct Values in Different Samples: Description of the cycle threshold (Ct) values in different types of samples. Since Ct values are numerical and specific to each sample type, you would present the Ct values for each type of sample separately. Duration of MPXV-PCR Positivity in Different Samples: Duration (in days) of MPXV-PCR positivity in each sample type

  Up to 2 months after the end of the epidemic, with a maximum of 2 years

• Characterize the longitudinal clinical course of PCR-confirmed cases

  * Frequency and Types of Complications: Measured as the percentage of patients experiencing complications (complications reported as counts or percentages). * In-hospital Mortality Rate and Cause of Death: Measured as the number of deaths per 100 patients, along with primary causes. * Duration of Signs and Symptoms: Measured in number of days from onset to resolution (could be overall or by category). * Frequency of Clinical Sequelae at Discharge (Day 28/59): Measured as the percentage of patients with complications at hospital discharge, Day 28, and Day 59. All these together will allow us to caracterise the clinical course of confirmed cases

  Up to 2 months after the end of the epidemic, with a maximum of 2 years

• Identification of viral shedding sites and appropriate sampling strategy

  Proportion of patients with VMPX-PCR positivity in the following samples: skin swab, oropharyngeal swab, saliva, urine, semen, breast milk, anal swab, vaginal swab Description of MPXV-PCR Ct values in different samples Duration of MPXV-PCR positivity in different samples

  Up to 2 months after the end of the epidemic, with a maximum of 2 years

• Characterize the virological evolution of confirmed cases

  Duration of MPXV-PCR positivity in different samples since date of diagnosis and since date of onset of symptoms Time course of CT values by sample type

  Up to 2 months after the end of the epidemic, with a maximum of 2 years

• Determine the seroconversion rate among confirmed cases of mpox

  Description of anti-VMPX antibody titres on days 0, 7, 14, 29 and 59 among VMPX-PCR-positive cases

  Up to 2 months after the end of the epidemic, with a maximum of 2 years

• Assess risk factors for mpox disease.

  Odds Ratios for Mode of Exposure: different types of exposure to mpox cases or animal reservoirs, with odds ratios calculated separately for each type of exposure. Odds Ratios for Socio-Demographic Factors: Odds ratios for the association between socio-demographic factors (such as age, gender, occupation) and the likelihood of mpox positivity. Odds Ratios for Comorbidities: odds ratios of various comorbidities (such as HIV, diabetes, etc.) and their association with mpox positivity. All together, these will allow us to estimate more clearly the mpox risk factors

  Up to 2 months after the end of the epidemic, with a maximum of 2 years

• To assess the protective effect of previous smallpox vaccination on symptomatic mpox disease.

  Vaccine efficacy based on determination of the odds ratio of vaccine status between mpox suspects tested positive and those tested negative in a test-negative case-control study.

  Up to 2 months after the end of the epidemic, with a maximum of 2 years

Secondary Outcomes (2)

• Assess genomic differences between VMPX strains isolated from confirmed cases of mpox due to sexual transmission and other modes of transmission

  Up to 2 months after the end of the epidemic, with a maximum of 2 years

• Support General Referral Hospital (GRH) Kamituga

  Up to 2 months after the end of the epidemic, with a maximum of 2 years

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

All persons applying to be tested for VMPX at HGR or another test center.

You may qualify if:

• To be tested for VMPX at the HGR or another testing center. Patients of all ages and sexes
• Minors (≤ 17 years) are excluded from genital, anal and semen sampling and follow-up blood sampling.
• Patient or culturally acceptable representative is willing and able to give informed consent for study participation.

Sponsors & Collaborators

• Institute of Tropical Medicine, Belgium: lead
• Ministry of Public Health, Democratic Republic of the Congo: collaborator
• Research Foundation Flanders: collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Kamituga General Hospital

Kamituga, Democratic Republic of the Congo

Location

Related Publications (1)

• Vakaniaki EH, Kacita C, Kinganda-Lusamaki E, O'Toole A, Wawina-Bokalanga T, Mukadi-Bamuleka D, Amuri-Aziza A, Malyamungu-Bubala N, Mweshi-Kumbana F, Mutimbwa-Mambo L, Belesi-Siangoli F, Mujula Y, Parker E, Muswamba-Kayembe PC, Nundu SS, Lushima RS, Makangara-Cigolo JC, Mulopo-Mukanya N, Pukuta-Simbu E, Akil-Bandali P, Kavunga H, Abdramane O, Brosius I, Bangwen E, Vercauteren K, Sam-Agudu NA, Mills EJ, Tshiani-Mbaya O, Hoff NA, Rimoin AW, Hensley LE, Kindrachuk J, Baxter C, de Oliveira T, Ayouba A, Peeters M, Delaporte E, Ahuka-Mundeke S, Mohr EL, Sullivan NJ, Muyembe-Tamfum JJ, Nachega JB, Rambaut A, Liesenborghs L, Mbala-Kingebeni P. Sustained human outbreak of a new MPXV clade I lineage in eastern Democratic Republic of the Congo. Nat Med. 2024 Oct;30(10):2791-2795. doi: 10.1038/s41591-024-03130-3. Epub 2024 Jun 13.

  PMID: 38871006 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

skin swab, oropharyngeal swab, saliva, urine, semen, breast milk, anal swab, vaginal swab

MeSH Terms

Conditions

Mpox, Monkeypox

Condition Hierarchy (Ancestors)

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

Study Officials

• Laurens Liesenborghs

  Institute of Tropical Medicine

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 59 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 22, 2024
• Study Start: March 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: October 22, 2024

Record last verified: 2024-10

Locations

DE (1)