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 range2 Years – 9 Years

SexALL

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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

✕. Current or prior use within last 6 months of any immunosuppression (e.g. intravenous immunoglobulin, steroids, interferon therapy)
✕. Treatment with another investigational drug, vaccine, or other intervention within six months of screening

What they're measuring

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

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)

Sponsor typeNIH

Study typeOBSERVATIONAL

Primary completion2022-01-25

View on ClinicalTrials.gov More Dengue Fever trials