UnknownNot Applicable

Biomarkers of P. Vivax Relapse

Thailand100 participantsStarted 2019-11-19

Plain-language summary

Plasmodium vivax malaria is difficult to manage because even after taking medicine that kills the infection in the blood, it can continue to hide quietly in the liver, later re-emerging into the blood and causing another episode of malaria illness (relapse). This clinical trial aims to enroll patient with P. vivax infections and try to detect signals in blood, urine and/or saliva coming from the silent liver stages to help identify who could benefit from treatment with primaquine. It also will explore if certain factors of patients negatively impact primaquine efficacy.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Are a Thai male or non-pregnant/non-lactating female aged at least 18 years and are able to fluently speak and understand Thai
✓. Willingness to participate in the study as evidenced by witnessed, signed informed consent from the subject (written or thumb print)
✓. Have P. vivax malaria mono-infection as determined by blood smear, with a parasitemia range of 100-400,000 parasites/microliter
✓. Are available to stay in a controlled setting for the first 28 days of this study to minimize exposure to mosquitoes and available for follow-up for anticipated study duration
✓. Resides in Sisaket or Ubon Ratchathani Province
✓. Are of normal (non-deficient or \>30% activity) G6PD phenotype as defined by WHO
✓. Agree to not seek outside medical care prior to contacting the Armed Forces Research Institute of Medical Sciences (AFRIMS) study team if a fever develops during study participation (approximately 180 days), unless emergency medical care is required
✓. Are a Thai male or non-pregnant/non-lactating female aged at least 18 years and are able to fluently speak and understand Thai

Exclusion criteria

What they're measuring

Therapeutic efficacy of a radical cure course of primaquine for uncomplicated P. vivax infection

Timeframe: 6 months

Build a biorepository of prospectively collected blood and urine samples in P. vivax patients prior to relapse to analyze for hypnozoite biomarkers

Timeframe: 6 months

Trial details

NCT IDNCT04228315

SponsorArmed Forces Research Institute of Medical Sciences, Thailand

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2021-06-30

Contact for this trial

Michele D Spring, MD

+66(0)2696-2700 michele.spring.ctr@afrims.org

View on ClinicalTrials.gov More Malaria trials