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

Phase 3

• Registration Number: PER-020-23
• Lead Sponsor: os Regentes de la Universidad de California

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-21
• Last Update Posted: 20 August 2024

Recruitment & Eligibility

• Status: Without startig enrollment
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

.

Primaquine
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

Exclusion Criteria

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

Primaquine
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

Study & Design

• Study Type: Interventional
• Study Design: Not specified