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临床试验/SLCTR/2022/018
SLCTR/2022/018招募中3 期

A cluster randomized, placebo control trial to evaluate the efficacy of a spatial repellent (Mosquito ShieldTM) against Aedes-borne virus infection among children >= 4–16 years of age in the Gampaha District, Sri Lanka

niversity of Notre Dame0 个研究点开始时间: 待定最近更新:
适应症

试验速览

阶段
3 期
状态
招募中
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • 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)
  • 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.
  • 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.
  • 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 abusive substances 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 abusive substances are sold, residents are always drunk or hostile).

排除标准

  • LONGITUDINAL SEROCONVERSION Individual Level
  • 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
  • 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 abusive substances 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
  • 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
  • Exclusion Criteria:
  • Adult head of household does not agree to surveys.
  • Properties where study personnel identify a security risk (i.e., site where abusive substances are sold, residents are always drunk or hostile).
  • SPATIAL REPELLENT INTERVENTION Household Level
  • 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 abusive substances are sold, residents are always drunk or hostile

研究者

发起方
niversity of Notre Dame

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