Investigating Vector-Borne Determinants of Aedes Transmitted Arboviral Infections in Cambodia: An… (NCT03534245) | Clinical Trial Compass
CompletedNot Applicable
Investigating Vector-Borne Determinants of Aedes Transmitted Arboviral Infections in Cambodia: An Observational Longitudinal Cohort Study in Children
Cambodia775 participantsStarted 2018-07-01
Plain-language summary
Background:
Some mosquitos carry viruses that can cause disease. Some examples are dengue and Zika. The mosquitos spread disease by biting people and infecting them with the virus. Children, elderly people, and people who are already sick are especially likely to get infected. Researchers want to learn more to help make new medicines to treat these viral infections.
Objective:
To learn more about how mosquitos infect people, and why young children are more likely to get sick than other people.
Eligibility:
Healthy children 2-9 years old who live near the study site. This is Kampong Speu District Referral Hospital in Chbar Mon, Cambodia.
Design:
At visit 1, participants will have a physical exam. A small amount of blood will be taken from their arm or finger. Parents will answer questions about the participant s general health and medical history.
Participants will come back to the study site every wet season and every dry season for the next 3 years. The visits will be the same as visit 1 and take about 1 hour.
If at any time during the study the participant gets a fever and has other symptoms that could be caused by these viral diseases, they should be brought to the study site. These symptoms might include headache, pain behind the eyes, muscle pain, or joint pain. They can also include a rash that lasts longer than 12 hours.
Participation ends after the final study visit in late 2021.
Who can participate
Age range
2 Years – 9 Years
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 signed and dated informed consent form
. Stated willingness to comply with all study procedures and availability for the duration of the study
. Male or female, aged 2-9 years
. Live within approximately 5.5 km of study site
. In good general health as evidenced by medical history
. Willing to allow biological samples to be stored for future research.
Exclusion criteria
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.
1This study tracked dengue infections in children aged 2 to 9 in Cambodia over three years — does my child's age, location, and exposure history make this kind of research relevant to understanding their own dengue risk?
2The trial measured both symptomatic dengue and inapparent infections where kids had no obvious symptoms — could my child have had a dengue infection in the past without us knowing, and does that affect how we should think about their health now?
3Since this was an observational study and not a treatment trial, it collected data but didn't test any medication or vaccine — does the kind of information it gathered about mosquito exposure patterns and dengue prevalence change any recommendations you'd make for protecting my child?
4The study tested children's immune reactions to Aedes aegypti mosquito saliva as a marker of mosquito biting exposure — is that type of mosquito bite exposure measurement something that could ever be relevant to my child's care or future vaccine eligibility decisions?
5Now that this study is completed, are there follow-on treatment trials or dengue vaccine studies in this region or age group that you think would be worth discussing as a next step for our family?
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 symptomatic and inapparent dengue infection (serotypes 1-4) as detected semiannually via ELISA assay (binary outcome present/absent) over a three-year period in Kampong Speu in children aged 2-9 years old
Timeframe: Semi-Annual visits and sick/convalescent visits throughout study enrollment
2
Prevalence of Aedes aegypti salivary gland homogenate reactivity as detected by ELISA assay (binary outcome present/absent) during wet and dry seasons over a three-year period in Kampong Speu in children aged 2-9 years old
Timeframe: Semi-annual visits and sick/convalescent visits throughout study enrollment
Trial details
NCT IDNCT03534245
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)