Home » Trials » SLCTR/2022/018 » Protocols
Date
2022-09-14
Protocol
Protocol changed
Item Changed
Secondary outcome(s)
Previous Version
1.Clinically apparent laboratory confirmed cases of Aedes-borne virus (ABV) disease. Compare laboratory confirmed Aedes-borne virus infection rates in subjects residing in households with active and placebo product, receiving standard entomological surveillance and control procedures by the Ministry of Health of Sri Lanka, as an indicator for ABV disease. Clinically apparent is defined as an acute infection that causes overt symptoms (fever, rash, etc.) indicating virus circulation in the blood. 2.Adult female Aedes aegypti indoor abundance. Compare adult female Aedes aegypti indoor abundance in households using Procopak mosquito aspiration with active and placebo product as an indicator for reduced mosquito house entry due to effect of product 3.Adult female Aedes aegypti blood fed rate. Compare adult female Aedes aegypti blood fed rate in households using direct abdominal observation by microscopy from Procopak mosquito aspiration sample with active and placebo product as an indicator for reduced mosquito human contact due to effect of product. 4.Diversion of Aedes aegypti mosquitoes into untreated houses. Compare adult female Aedes aegypti abundance using Procopak mosquito aspiration in untreated households adjacent to treatment clusters (with active product) to untreated households adjacent to placebo clusters as an indicator for mosquito diversion due to effect of product. 5.Overall incidence of Aedes-borne virus (ABV) infection. Seroconversion rates of all children enrolled in the trial, independent of order of infection (i.e., including tertiary and quaternary infections). 6.Adverse Events (AEs) and Serious Adverse Events (SAEs). Measured by solicited and unsolicited reports during the trial period. Mean, minimum and maximum frequency and percentage of AEs and SAEs across clusters among enrolled subjects will be summarized by treatment arm. 7.Incidence of Aedes-borne virus (ABV) infection in subjects residing in households within treatment clusters but without SR product. Compare Aedes-borne virus infection rates between subjects residing in households with SR product in treatment clusters and subjects from the same clusters who did not agree to the SR application in their households but are receiving standard entomological surveillance and control procedures by the local ministry of health, as an indicator of community effect due to effect of product. 8.Clinically apparent laboratory confirmed cases of Aedes-borne virus (ABV) disease in subjects residing in households within treatment clusters but without SR product. Compare laboratory confirmed Aedes-borne virus infection rates between subjects residing in households with SR product in households in treatment clusters and individuals from the same clusters who did not agree to the SR application in their households but are receiving standard entomological surveillance and control procedures by the local ministry of health, as an indicator of community effect due to effect of product. 9.Adult female Aedes aegypti indoor abundance using Procopak mosquito aspiration in households within treatment clusters but without SR product. Compare adult female Aedes aegypti indoor abundance in households with SR product in treatment clusters and households from the same clusters who did not agree to the SR application but are receiving standard entomological surveillance and control procedures by the local ministry of health, as an indicator of community effect to effect of product. 10.Adult female Aedes aegypti blood fed rate using Procopak mosquito aspiration in households within treatment clusters but without SR product. Compare adult female Aedes aegypti blood fed rate in households with SR product in treatment clusters and households from the same clusters who did not agree to the SR application but are receiving standard entomological surveillance and control procedures by the local ministry of health, as an indicator of community effect to effect of product.
Next Version
1.Clinically apparent laboratory confirmed cases of Aedes-borne virus (ABV) disease. Compare laboratory confirmed Aedes-borne virus infection rates in subjects residing in households with active and placebo product, receiving standard entomological surveillance and control procedures by the Ministry of Health of Sri Lanka, as an indicator for ABV disease. Clinically apparent is defined as an acute infection that causes overt symptoms (fever, rash, etc.) indicating virus circulation in the blood. 8.Clinically apparent laboratory confirmed cases of Aedes-borne virus (ABV) disease in subjects residing in households within treatment clusters but without SR product. Compare laboratory confirmed Aedes-borne virus infection disease cases rates between subjects residing in households with SR product in households in treatment clusters and individuals from the same clusters who did not agree to the SR application in their households but are receiving standard entomological surveillance and control procedures by the local ministry of health, as an indicator of community effect due to effect of product.