Mpox (Monkeypox)NCT06652646
Mpox Biology, Outcome, Transmission and Epidemiology
An observational study of Mpox (Monkeypox), run by Institute of Tropical Medicine, Belgium at 1 site in Democratic Republic of the Congo.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mpox (Monkeypox)
- How many people
- 1,000 participants
- Where
- 1 siteDemocratic Republic of the Congo
- Study dates
- 1 Mar 2024to May 2025
- How long will I take part?
- 59 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All persons applying to be tested for VMPX at HGR or another test center.
Who may be able to join
- 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.
Who cannot join
- NA
Trial locations and contacts
1 site in 1 country.
Democratic Republic of the Congo1 site
Kamituga General Hospital
Kamituga
About this study
Official title: MBOTE-Kamituga / Mpox Biology, Outcome, Transmission and Epidemiology - Protocole De Caractérisation Clinique Et Virologique Des Infections À Virus De Monkeypox À Kamituga (MBOTE-Kamituga)
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.
Read the detailed description
For several decades, the Democratic Republic of Congo (DRC) has been the country most affected by monkeypox. While the global monkeypox epidemic (commonly known as mpox) of 2022-2023 was caused by clade II monkeypox virus (VMPX), outbreaks in the DRC are caused by the more virulent clade I variant. In recent years, and particularly in 2023, the country has seen a sharp increase in the number of cases, as well as a geographical expansion of the disease, with previously unaffected regions now reporting cases. Until recently, VMPX infections in the DRC were thought to be primarily the result of zoonotic transmission, with rather limited secondary human-to-human transmission. However, in recent months, an increasing number of cases linked to sexual transmission of clade I have been reported.
The Kamituga health zone is a densely populated mining region in South Kivu. The region reported no cases of smallpox in recent decades until, in October 2023, the disease was detected for the first time and began to affect mainly adolescents and young adults. To date, nearly 200 cases have been reported to health authorities, although the actual number of cases may be much higher due to significant under-reporting. Preliminary data show that the epidemic is mainly due to heterosexual transmission, and that up to 30% of cases are reported by sex workers, many of whom come from Burundi, Rwanda, Uganda and Tanzania. The ongoing transmission poses a significant risk of cross-border spread and could therefore lead to a new global smallpox epidemic, this time caused by the more virulent clade I.
The study will be carried out in collaboration with the Direction Provincial de la Santé/Kamituga and the Programme National de Lutte contre le Monkeypox et les Fièvres Virales Hémorragiques (PNLMPX/FVH) in the Kamituga Health Zone. Participants will be recruited at the Kamituga general referral hospital (HGR) or at health centers that provide mpox screening and treatment.
The MBOTE (Monkeypox Biology, Outcome, Transmission and Epidemiology) project is a multidisciplinary research collaboration between the National Institute for Biomedical Research (INRB), the Antwerp Institute of Tropical Medicine (ITM Antwerp) and the University of Antwerp.
This research protocol aims to better understand the mpox epidemic currently raging in the Kamituga SZ, as well as to provide more general information on the disease. The protocol describes the research activities that will be integrated into the ongoing epidemic investigation and control activities. Research activities will be aligned as far as possible with the ongoing epidemic response and should not hinder the response, but rather support it.
Similarly, sample collection will be aligned with the sampling carried out by the national program, and some samples will undergo additional analysis to answer the research objectives and questions.
Participation in this epidemic investigation protocol will in no way prevent patients from taking part in any other research study.
The study will be aligned as far as possible with the investigation and management of the epidemic by the national program. The study will therefore run for up to 2 months after the end of the epidemic (for convalescent patients who can be followed up for up to 2 months (day 59) after confirmation of infection), or could run for 2 years whether or not the epidemic is over. The shorter duration will be chosen, so as not to delay the reporting of results to the competent authorities, which will be essential for informing control and research activities in subsequent epidemics.
There is no fixed sample size defined for this protocol. On the contrary, as far as possible, all patients with suspected mpox will be included in the study.
- Conditions
- Mpox (Monkeypox)
- Medical subject headings
- Mpox, Monkeypox
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Whole genome sequencing of VMPX strains from confirmed cases of mpox due to sexual transmission and other modes of transmission
Measured: Up to 2 months after the end of the epidemic, with a maximum of 2 years
Support General Referral Hospital (GRH) Kamituga
Number of suspected and confirmed mpox cases managed at GRH Kamituga, with outcomes recorded as successful management or complications.
Number of patients tested using the GeneXpert system, with diagnostic accuracy and turnaround time measured.
Number of healthcare workers trained on mpox diagnosis and management, with training effectiveness assessed through pre- and post-training evaluations.
Measured: Up to 2 months after the end of the epidemic, with a maximum of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start1 Mar 2024
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mpox (Monkeypox)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 59 Days
Sponsor and investigators
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Public Health, Democratic Republic of the Congo, Research Foundation Flanders, National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Laurens Liesenborghs, Study director, Institute of Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06652646
- Sponsor's protocol ID
- Project 427100 MPX
- Status last verified
- Oct 2024
- First submitted
- 11 Oct 2024
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38871006
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MBOTE-Kamituga / Mpox Biology, Outcome, Transmission and Epidemiology - Protocole De Caractérisation Clinique Et Virologique Des Infections À Virus De Monkeypox À Kamituga (MBOTE-Kamituga)
- ClinicalTrials.gov ID
- NCT06652646
- Acronym / sponsor ID
- Project 427100 MPX
- Conditions
- Mpox (Monkeypox)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Institute of Tropical Medicine, BelgiumUniversity, hospital or other
- Collaborators
- Ministry of Public Health, Democratic Republic of the Congo, Research Foundation Flanders, National Institutes of Health (NIH)
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 22 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
For several decades, the Democratic Republic of Congo (DRC) has been the country most affected by monkeypox. While the global monkeypox epidemic (commonly known as mpox) of 2022-2023 was caused by clade II monkeypox virus (VMPX), outbreaks in the DRC are caused by the more virulent clade I variant. In recent years, and particularly in 2023, the country has seen a sharp increase in the number of cases, as well as a geographical expansion of the disease, with previously unaffected regions now reporting cases. Until recently, VMPX infections in the DRC were thought to be primarily the result of zoonotic transmission, with rather limited secondary human-to-human transmission. However, in recent months, an increasing number of cases linked to sexual transmission of clade I have been reported.
The Kamituga health zone is a densely populated mining region in South Kivu. The region reported no cases of smallpox in recent decades until, in October 2023, the disease was detected for the first time and began to affect mainly adolescents and young adults. To date, nearly 200 cases have been reported to health authorities, although the actual number of cases may be much higher due to significant under-reporting. Preliminary data show that the epidemic is mainly due to heterosexual transmission, and that up to 30% of cases are reported by sex workers, many of whom come from Burundi, Rwanda, Uganda and Tanzania. The ongoing transmission poses a significant risk of cross-border spread and could therefore lead to a new global smallpox epidemic, this time caused by the more virulent clade I.
The study will be carried out in collaboration with the Direction Provincial de la Santé/Kamituga and the Programme National de Lutte contre le Monkeypox et les Fièvres Virales Hémorragiques (PNLMPX/FVH) in the Kamituga Health Zone. Participants will be recruited at the Kamituga general referral hospital (HGR) or at health centers that provide mpox screening and treatment.
The MBOTE (Monkeypox Biology, Outcome, Transmission and Epidemiology) project is a multidisciplinary research collaboration between the National Institute for Biomedical Research (INRB), the Antwerp Institute of Tropical Medicine (ITM Antwerp) and the University of Antwerp.
This research protocol aims to better understand the mpox epidemic currently raging in the Kamituga SZ, as well as to provide more general information on the disease. The protocol describes the research activities that will be integrated into the ongoing epidemic investigation and control activities. Research activities will be aligned as far as possible with the ongoing epidemic response and should not hinder the response, but rather support it.
Similarly, sample collection will be aligned with the sampling carried out by the national program, and some samples will undergo additional analysis to answer the research objectives and questions.
Participation in this epidemic investigation protocol will in no way prevent patients from taking part in any other research study.
The study will be aligned as far as possible with the investigation and management of the epidemic by the national program. The study will therefore run for up to 2 months after the end of the epidemic (for convalescent patients who can be followed up for up to 2 months (day 59) after confirmation of infection), or could run for 2 years whether or not the epidemic is over. The shorter duration will be chosen, so as not to delay the reporting of results to the competent authorities, which will be essential for informing control and research activities in subsequent epidemics.
There is no fixed sample size defined for this protocol. On the contrary, as far as possible, all patients with suspected mpox will be included in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 59 Days
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All persons applying to be tested for VMPX at HGR or another test center.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- NA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Characterize the clinical presentation of suspected mpox cases
Time frame: Up to 2 months after the end of the epidemic, with a maximum of 2 years
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
Characterize the longitudinal clinical course of PCR-confirmed cases
Time frame: Up to 2 months after the end of the epidemic, with a maximum of 2 years
* 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
Identification of viral shedding sites and appropriate sampling strategy
Time frame: Up to 2 months after the end of the epidemic, with a maximum of 2 years
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
Characterize the virological evolution of confirmed cases
Time frame: Up to 2 months after the end of the epidemic, with a maximum of 2 years
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
Determine the seroconversion rate among confirmed cases of mpox
Time frame: Up to 2 months after the end of the epidemic, with a maximum of 2 years
Description of anti-VMPX antibody titres on days 0, 7, 14, 29 and 59 among VMPX-PCR-positive cases
Assess risk factors for mpox disease.
Time frame: Up to 2 months after the end of the epidemic, with a maximum of 2 years
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
To assess the protective effect of previous smallpox vaccination on symptomatic mpox disease.
Time frame: Up to 2 months after the end of the epidemic, with a maximum of 2 years
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.
2 secondary outcomes
Assess genomic differences between VMPX strains isolated from confirmed cases of mpox due to sexual transmission and other modes of transmission
Time frame: Up to 2 months after the end of the epidemic, with a maximum of 2 years
Support General Referral Hospital (GRH) Kamituga
Time frame: Up to 2 months after the end of the epidemic, with a maximum of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
- Background: PubMed 38871006Vakaniaki 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurens Liesenborghs study director
Institute of Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mpox (Monkeypox), run by Institute of Tropical Medicine, Belgium at 1 site in Democratic Republic of the Congo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Democratic Republic of the Congo. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterize the clinical presentation of suspected mpox cases (time frame: Up to 2 months after the end of the epidemic, with a maximum of 2 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06652646, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2024.