Evaluation of Tafenoquine for the Post-Exposure Prophylaxis of Vivax Malaria (Southwest Pacific Type) in Non-Immune Australian Soldiers

Phase 2

Completed

• Conditions: Malaria; Infection - Other infectious diseases

• Registration Number: ACTRN12607000588493
• Lead Sponsor: GlaxoSmithKline

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-11-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Glucose-6-Phosphate Dehydrogenase (G6PD) normal,
Healthy adults

Exclusion Criteria

Pregnant females or females unwilling to use contraception for 30 days following completion of dosing,
G6PD deficiency,
Taking any other investigational drug within 30 days of last dose,
unwilling or unable to give blood.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary efficacy parameter was the proportion of subjects with confirmed parasitemia during the 12-month follow-up period[Follow up to 12 months]

Secondary Outcome Measures

Name	Time	Method
Time to parasitaemia[12 months];Tolerability[Clinical interview at day 3.];Biochemical safety and pharmacokinetic analysis[Blood sampling at day 0 and day 3]