Epidemiological and Clinical Characteristics of Human Mpox Outbreak in Equateur Province in the D… (NCT07067723) | Clinical Trial Compass
By InvitationNot Applicable
Epidemiological and Clinical Characteristics of Human Mpox Outbreak in Equateur Province in the Democratic Republic of Congo (Part2)
Democratic Republic of the Congo122 participantsStarted 2024-08-01
Plain-language summary
The goal of this observational study is
* to better understand the dominant modes of transmission
* to estimate the extent of transmission among contacts by determining the secondary infection rate for human-to-human transmission at an individual level and identifying factors associated with secondary infections.
* to determine the proportion of asymptomatic or pauci-symptomatic infections.
* to characterize the incubation period of mpox and the duration of infectiousness, including reproduction numbers.
* to assess serological responses following confirmed infection.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Provision of informed consent:
Proxy-assisted informed consent is allowed under safety considerations. Following oral consent, the investigator will document this on the informed consent form as a witness.
Fulfillment of the current mpox clinical case definition in the DRC, which includes:
Presence of a vesicular or pustular eruption with deep-seated, firm pustules.
At least one of the following symptoms:
Fever preceding the eruption. Lymphadenopathy (inguinal, axillary, or cervical). Presence of pustules or crusts on the palms of the hands or soles of the feet.
Laboratory confirmation:
At least one molecular-based mpox diagnostic test confirming the diagnosis.
Exclusion Criteria:
* Participants will be excluded from the study under the following conditions:
Refusal to participate in the study:
Individuals who decline to provide consent for study participation will be excluded
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Transmission chain
Timeframe: through study completion, average 4 weeks
2
Incubation Period
Timeframe: through study completion, an average 4 weeks
3
Serial Interval
Timeframe: through study completion, an average 4 weeks
4
Secondary Attack Rate (SAR)
Timeframe: through study completion, an average 4 weeks
5
Effective Reproduction Number (Re)
Timeframe: through study completion, an average of 2 years