Focal mass drug Administration for vivax Malaria Elimination (FLAME): a pragmatic cluster randomized controlled trial in Peru

os Regentes de la Universidad de California0 个研究点目标入组 0 人开始时间: 2024年2月21日最近更新: 2024年8月20日

试验速览

暂无简介。

•1. Eligible to receive CQ and ineligible to receive TQ
•2. Age =6 months old
•3. Adult =18 years old that provides informed consent
•4. A child =8 years and <18 years old that provides informed assent and has informed consent from their parents
•5. A child =6 months old and <8 years old that has informed consent from their parents
•Chloroquine
•1. Resides in neighboring household but within 200 m of Pv index case in the past 2 years
•2. Age =6 months old
•3. Present for intervention
•4. Adult =18 years old that provides informed consent
•5. A child =8 years and <18 years old that provides informed assent and has informed consent from their parents
•6. A child =6 months old and <8 years old that has informed consent from their parents
•Tafenoquine
•1. Eligible to receive CQ
•2. Age =16 years old
•3. Adult =18 years old that provides informed consent
•4. A child =16 years and <18 years old that provides informed assent and has informed consent from their parents

•Chloroquine
•1. History of retinal or visual field changes
•2. Known hypersensitivity or adverse reaction to CQ
•3. Currently taking CQ or have taken CQ in the past four weeks
•4. Ineligible for TQ or PQ (see criterio below)
•5. Hemoglobin <7 g/dL
•Tafenoquine
•1. G6PD deficiency or intermediate status (defined as activity =6 UI/gHb per SD biosensor)
•2. G6PD status unknown or refusal of G6PD status test
•3. Acute or severe malaria
•4. Pregnancy (known or identified by pregnancy test)
•5. Refusal of pregnancy test if new amenorrhea in the past 4 weeks
•6. Woman breastfeeding to child that is G6PD deficient or with unknown G6PD status
•7. Known hypersensitivity or adverse reaction to TQ or PQ
•8. Have taken mefloquine (i.e. artesunate-mefloquine), TQ or PQ, or other antimalarial in the past four weeks
•9. Hemoglobin < 7 g/dL
•1. G6PD deficiency (defined as activity <4 UI/gHb per SD biosensor)
•2. G6PD status unknown or refusal of G6PD status test
•3. Acute or severe malaria
•4. Pregnancy (known or identified by pregnancy test)
•5. Refusal of pregnancy test if new amenorrhea in the past 4 weeks
•6. Infant child with G6PD deficiency or unknown G6PD status
•7. Known hypersensitivity or adverse reaction to TQ or PQ
•8. Have taken mefloquine (i.e. artesunate-mefloquine), TQ or PQ, or other antimalarial in the past four weeks
•9. Hemoglobin < 7 g/dL

发起方

os Regentes de la Universidad de California