Streptococcus Pyogenes Carriage Acquisition and Transmission Study (NCT05117528) | Clinical Trial Compass
CompletedNot Applicable
Streptococcus Pyogenes Carriage Acquisition and Transmission Study
The Gambia441 participantsStarted 2021-07-27
Plain-language summary
Group A Streptococcus (GAS) is a bacteria which causes severe infections and leads to deadly diseases such as rheumatic heart disease which kills over 300,000 people a year globally, particularly in low-income countries. It is not know how GAS is spread between people, how often people carry GAS in their throat or on their skin without having symptoms, or what factors increase the chance of this occurring. It is important to understand these factors in order to know how to reduce GAS-related disease.
This study will follow 444 people in The Gambia, over 12 months, taking samples from the throats and skin of people living in the same households, and asking questions about themselves and their behaviour, at regular intervals. By taking samples over time, the investigators hope to understand how common it is to carry GAS without having symptoms, how GAS is spread between people, and whether carrying GAS leads to more GAS infections in people or their household members.
The study will use state-of-the-art techniques to look at the DNA of GAS bacteria that we find, and combine this with a mathematical model to investigate how different strains spread to people within and between households in the community.
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:
Households must:
* Be within the boundary of Sukuta as determined by the 2013 census
* Have at least 3 members including at least one child under age 18
Individuals must:
* Provide signed (or thumbprinted) informed consent for study participation (obtained from a parent or guardian for children under the age of 18
* Be willing and have capacity to participate and comply with the study protocol as judged by a member of the study team
* Be resident in the household, with no plans to move outside of the household during the period of study participation
Exclusion Criteria:
Households:
\- Less than 80% of individuals living in the household, as defined by the The Gambia Demographic and Health Survey 2013 definition, provide consent to participate
Individuals:
* Consent not provided
* Has any condition or any other reason that may lead to difficulty or discomfort in obtaining all the necessary samples
* Is judged by the study team member to be unable or unlikely to participate and comply with the study protocol for the entire study period
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
Prevalence of oropharyngeal swabs positive for GAS each month
Timeframe: Monthly visits
2
Prevalence of normal skin swabs positive for GAS each month
Timeframe: Monthly visits
3
Incidence of GAS-positive oropharyngeal swabs
Timeframe: 1 year
4
Incidence of GAS-positive normal skin swabs
Timeframe: 1 year
5
Change in GAS-positive swabs per month
Timeframe: 1 year
Trial details
NCT IDNCT05117528
SponsorLondon School of Hygiene and Tropical Medicine