Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06652646
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-10-11
Brief Title:
Mpox Biology Outcome Transmission and Epidemiology
Sponsor:
None
Organization:
None
Study Overview
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
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 SantéKamituga and the Programme National de Lutte contre le Monkeypox et les Fièvres Virales Hémorragiques PNLMPXFVH 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
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 SantéKamituga and the Programme National de Lutte contre le Monkeypox et les Fièvres Virales Hémorragiques PNLMPXFVH 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None