None listed
Conditions
Brief summary
The primary purpose of this study is to determine the safety and tolerability of weekly tafenoquine in healthy Vietnamese military personnel on peacekeeping duties in South Sudan by performing regular clinical and blood chemistry assessments.. Additionally, the effectiveness of tafenoquine in protecting the participants against malaria infections will be determined by monitoring their blood samples for malaria parasites using rapid diagnostic testing and blood film microscopy. Weekly tafenoquine regimen is more convenient to take with potentially improved compliance than daily doxycycline or atovaquone-proguanil (Malarone), the other recommended prophylactic agents by the World Health Organization (WHO, 2017) for malaria prevention. WHO also recommends weekly mefloquine but the drug is associated with neurological disturbances in some individuals. To our knowledge, this would be the second study to evaluate weekly 200 mg tafenoquine in a military force on peacekeeping duties in a malarious country. The study will provide the opportunity to compare the same tafenoquine regimen in an Asian population with that of a Caucasian population (i.e. Australian soldiers - Nasveld et al. Tafenoquine Study Team. Randomized, double-blind study of the safety, tolerability, and efficacy of tafenoquine versus mefloquine for malaria prophylaxis in nonimmune subjects. Antimicrob Agents Chemother. 2010;54:792-798) to see whether there are ethnic differences in the safety and tolerability of tafenoquine over a 6 month deployment period.
Interventions
Tafenoquine tablets will be administered orally, with a loading dose of 200 mg daily for 3 consecutive days followed by weekly (200 mg) dosing for 25 weeks.
Sponsors
Australian Defence Force Malaria and Infectious Disease Institute
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1) Adults (male and female). 2) Glucose-6-phospate dehydrogenase (G6PD) normal enzyme activity levels (>70%) of the site median value for G6PD normals using a quantitative G6PD test. 3) Willing and able to comply with all monitoring visits, physical examination, adverse events questionnaire, laboratory tests, and other study procedures. 4) Willingness to complete an acceptability questionnaire. 5) Completion of the written informed consent process prior to undertaking any study-related procedure.
Exclusion criteria
1) G6PD deficiency. 2) Prior or current history of nervous system and psychiatric disorders. 3) Any participant who is directly involved in conducting the study. 4) Any participant with poor peripheral venous access for blood sampling. 5) Known hypersensitivity reactions to primaquine. 6) Pregnant women.
Outcome results
None listed