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Completed

NCT Number: NCT01640574

Comparison Between 7 and 14 Day Primaquine Combined With Dihydroartemisinin-piperaquine or 3 Day Chloroquine Radical Cure of P. Vivax (BPD)

In Southeast Asia, Plasmodium vivax (Pv) infection reaches 50-80% and bears a greater burden of disease than Plasmodium falciparum (Pf). As control over Pf improves, Pv will assume increasingly larger percentages of malaria prevalence. The chronicity of Pv, due to the latent liver stage (hypnozoite) not eradicated by chloroquine, causes recurring disability and compounds the economic burden of those with symptomatic disease. The only widely available treatment for hypnozoites is primaquine, which, because of challenges with tolerability, safety in G6PD deficient persons, and compliance, is not commonly prescribed for the treatment of Pv. Currently, chloroquine is used for the treatment of the blood stages of Pv, however, there are concerns about increasing parasite resistance. Alternative treatments, such as artesunate, should be considered in the future of the treatment of blood stage Pv. The use of primaquine in the treatment of hypnozoites (radical cure) should be emphasized so that transmission of Pv can be controlled.

This study aims to determine the optimal primaquine regimen for radical cure of Plasmodium vivax. Chloroquine is currently the standard of treatment for Plasmodium vivax. Chloroquine may have synergistic effects when used with primaquine and due to its long half-life may delay the first relapse of vivax malaria. In contrast, artesunate does not have documented interactions with primaquine and has a very short half-life, thus, presumably will have no impact on first relapse. Combining primaquine with these two anti-malarials may lead to an alternative regimen for Pv infection and changing the primaquine dosing regimen may lead to a more practical and efficacious therapy.

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Key information

Age range

6 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Shoklo Malaria Research Unit

Mae Sot, Changwat Tak, 63110, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥ 6 months old
  • Microscopic diagnosis of Plasmodium vivax malaria mono-infection
  • Participant or parent/guardian is willing and able to give informed consent for participation in the study
  • Able (in the Investigators opinion) and willing to comply with all study requirements.

Exclusion criteria

  • Severe malaria
  • History of allergy or adverse reaction to artesunate, piperaquine, chloroquine, or primaquine
  • Blood transfusion in the past 3 months
  • G6PD deficiency by rapid test
  • Hematocrit ≤ 25%
  • Pregnancy at the time of screening
  • Breastfeeding an infant < 6 months old
  • Presence of any condition which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study

Treatment and study plan

Dihydroartemisinin-Piperaquine

Drug

Dihydroartemisinin-piperaquine + Primaquine: DHA-P 7mg/kg/day dihydroartemisinin and 55mg/kg/day piperaquine daily for 3 days and Primaquine 1 mg/kg once daily for 7 days

Chloroquine

Drug

Chloroquine + Primaquine: Chloroquine 10, 10, 5 and Primaquine 1 mg/kg once daily for 7 days

Primary outcomes

  1. Recurrence of P. vivax

    Time frame: 52 weeks

    Recurrence with Plasmodium vivax malaria within 52 weeks of first treatment dose

Secondary outcomes

  1. Adverse Events

    Time frame: 28 days

    Number of adverse events within 28 days of study medication

  2. Recurrence of P. vivax

    Time frame: 6 months

    Recurrence with Plasmodium vivax malaria within 6 months of first treatment dose

  3. Drug concentrations

    Time frame: 63 days

    Chloroquine, piperaquine and primaquine drug levels

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Registry information

Official study title

Randomised Parallel Open Label Comparison Between 7 and 14 Day Primaquine Combined With 3-day Dihydroartemisinin-piperaquine or 3-day Chloroquine Regimens for Radical Cure of Plasmodium Vivax

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jul 13, 2012
Registry last updated
Apr 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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