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

Comparison of three different dose regimens of tafenoquine versus primaquine for post-exposure prophylaxis of Plasmodium vivax malaria in the Southwest Pacific.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000588493

Acronym

TQ049

Enrollment

600

Registered

2007-11-16

Start date

1999-02-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Assessment of various tafenoquine dose regimens to determine the most effective dose for post exposure prophylaxis of P.vivax malaria in the Southwest Pacific

Interventions

Comparison of different tafenoquine regimens for tolerability and efficacy of malaria prevention. Tafenoquine doses of 400mg once daily, 200mg twice daily and 200mg once daily were given to volunteers orally for 3 days prior to departure from a malarious area.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Outcome results