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Sponsor: University of Notre Dame
Conditions: Arbovirus Infections
Interventions: Transfluthrin, Placebo
Countries: Sri Lanka
The primary objective of the study is to demonstrate and quantify the protective efficacy (PE) of a single SR product, in reducing DENV infection and active Aedes-borne virus (ABV) disease in human cohorts. The study design will be a prospective, cluster randomized controlled trial (cRCT). Although not a specific objective of this project, an overall goal is to allow for official recommendations (or not) from the World Health Organization (WHO) for the use of SRs in public health. A WHO global policy recommendation will establish evaluation systems of SR products to regulate efficacy evaluations, thereby increasing quality, overall use and a consequent reduction in disease.
Sex: ALL
Age: 6 Months to —
Healthy volunteers: Yes
Study type: INTERVENTIONAL
LONGITUDINAL SEROCONVERSION Individual Level Inclusion Criteria: * ≥ 4 - 16 years of age * Plans to stay in residence and/or study area for a minimum of 24 months * Resident of household or frequent visitor (\~20% of day hours in house / month) Exclusion Criteria: * \< 4 and \> 16 years of age * Plans to leave residence and/or study area within next 24 months * Temporary visitor to household (\<20% of day hours in house/ month) FEBRILE SURVEILLANCE Household Level Inclusion Criteria: * Adult head of households agrees to census, health visits and logging resident symptoms when febrile (or in the case of suspected Zika in the absence of fever, presenting with rash, arthralgia, arthritis or non-purulent conjunctivitis). * Individuals spend a minimum of 4hrs per week during the daytime hours or sleep in the house. Exclusion Criteria: * Adult head of households does not agree to census, health visits or logging symptoms of residents. * Households where study personnel identify a security risk (i.e., site where drugs are sold, residents are always drunk or hostile). * Sites where no residents spend time during the day (i.e. work 7d a week outside the home). FEBRILE SURVEILLANCE Individual Level Inclusion Criteria: * ≥ 6mo of age. * Fever at the time of presentation or report of feverishness within the previous 24 hours or presenting with a rash, arthralgia, arthritis or non-purulent conjunctivitis (suspicion of ZIKA determined by project physician) * Individual who spends a minimum of 4 hours per week within the household or sleeps in the house. Exclusion Criteria: * \< 6mo of age. * No fever at time of presentation or report of feverishness within the previous 24 hours or not reporting with a rash, arthralgia, arthritis or non-purulent conjunctivitis * Individuals who have spent less than 4 hours in the household during the week prior to illness. ENTOMOLOGICAL MONITORING Household Level Inclusion Criteria: * Adult head of household agrees to surveys. * Properties where study personnel do not identify a security risk (i.e., site where drugs are sold, residents are always drunk or hostile). Exclusion Criteria: * Adult head of household does not agree to surveys. * Properties where study personnel identify a security risk (i.e., site where drugs are sold, residents are always drunk or hostile). SPATIAL REPELLENT INTERVENTION Household Level Inclusion Criteria: * Adult head of households agrees to have intervention applied inside the home and to provide access to team member at 4-week intervals to change products. * Properties where study personnel do not identify a security risk (i.e., site where drugs are sold, residents are always drunk or hostile). Exclusion Criteria: * Adult head of household does not agree to Mosquito ShieldTM deployment or study team access. * Properties where study personnel identify a security risk (i.e., site where drugs are sold, residents are always drunk or hostile).
- Colombo, West, Sri Lanka
- Ragama, West, Sri Lanka