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New treatment option for Plasmodium Vivax Malaria
Official title Southeast Asia Dose Optimization of Tafenoquine
ClinicalTrials.gov ID: NCT04704999
What this study is testing
What is Tafenoquine?
Tafenoquine is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for plasmodium vivax malaria.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Tafenoquine was recently approved by regulatory authorities in the USA and Australia. Tafenoquine is an alternative radical curative treatment to primaquine acting against the dormant liver stage of Plasmodium vivax (the hypnozoite).
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 and older
You may be able to join if
- Patients with symptomatic P. vivax mono-infection as diagnosed by microscopy
- Fever or history of fever in the previous 7 days
- Quantitative G6PD activity ≥70% of the population median
- Weight \>10 kg and ≥2 years old
- Ability to understand the study instructions and provide written informed consent.
You likely can't join if
- Pregnancy
- Lactation
- Hb \< 8 g/dL
- Severe malaria
- Blood transfusion in the last 4 months
- History of allergic response to an 8-aminoquinoline or the nationally recommended schizonticide (e.g., chloroquine, artemether-lumefantrine)
See the full eligibility criteria
- Patients with symptomatic P. vivax mono-infection as diagnosed by microscopy
- Fever or history of fever in the previous 7 days
- Quantitative G6PD activity ≥70% of the population median
- Weight \>10 kg and ≥2 years old
- Ability to understand the study instructions and provide written informed consent.
- Willing to be followed for 4 months
- Pregnancy
- Lactation
- Hb \< 8 g/dL
- Severe malaria
- Blood transfusion in the last 4 months
- History of allergic response to an 8-aminoquinoline or the nationally recommended schizonticide (e.g., chloroquine, artemether-lumefantrine)
- Any previous history of a haemolytic event Presence of any condition which in the judgement of the investigator would place the patient at undue risk or interfere with the results of the study (e.g. chronic disease...
The study team makes the final eligibility decision.
Where it's taking place
- Siem Reap, Cambodia
- Vientiane, Laos
- Bangkok, Thailand
- Bình Phước, Vietnam
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Siem Reap, Cambodia; Vientiane, Laos; Bangkok, Thailand; Bình Phước, Vietnam. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.