Clinical Research Directory

Tafenoquine Drug Levels in Small Children

Sponsor: University of Oxford

Summary

This study is an open label, single arm, pharmacokinetic trial. A total of 20 participants (children ≤12kg and \>28 days old) will be enrolled. Enrollment will be competitive between Thailand and Vietnam study sites (each site will enroll as many patients that are eligible until the sample size is reached). Tafenoquine will be given concomitantly with the schizonticidal agent, chloroquine, on the day of enrolment. The participant will be admitted to hospital for observation and until the malaria smear is negative for asexual parasites on 2 consecutive days or until the schizonticidal treatment is completed, which will be approximately 3-7 days. All treatment doses will be supervised. Follow up will continue on days 7, 14, 21, and 28 then every month until month 4. Parent/guardian of participants will be instructed to follow up in between visits if participants are feeling unwell. Participants who are lost to follow up (any missed visit), who require drug re-administration after vomiting, or where at least 3 pharmacokinetic samples are not successfully drawn, will be replaced. Participants being replaced will continue in the study for safety assessments and to ensure the treatment of recurrences. The total blood drawn for this study will be 3.76 mL if the participant has no recurrences.

Official title: Characterising the Pharmacokinetics of Tafenoquine Under Fed Conditions for Plasmodium Vivax Radical Cure in Children ≤12kg and >28 Days Old

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