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AzTrials

Vivax MalariaPhase 3NCT01640574

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

A Phase 3 study testing Dihydroartemisinin-Piperaquine and Chloroquine in people with Vivax Malaria, run by University of Oxford at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 6 months and older
Conditions the study is for
Vivax Malaria
What is being tested?
Dihydroartemisinin-Piperaquine and Chloroquine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
680 participants
Where
1 siteThailand
Study dates
Feb 2012to Dec 2015
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • ≥ 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • Shoklo Malaria Research Unit

    Mae Sot, Changwat Tak, 63110

Other trials in Thailand

About this study

Official 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

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.

Conditions
Vivax Malaria
Being tested
Dihydroartemisinin-Piperaquine, Chloroquine
Keywords
Vivax, Chloroquine, Primaquine, Dihydroartemisinin-Piperaquine
Medical subject headings
Malaria, Vivax

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dihydroartemisinin-PiperaquineDrug

    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

  • Dihydroartemisinin-PiperaquineDrug

    Dihydroartemisinin-piperaquine + Primaquine: DHA-P 7mg/kg/day dihydroartemisinin and 55mg/kg/day piperaquine daily for 3 days Primaquine 0.5 mg/kg daily for 14 days

  • ChloroquineDrug

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

  • ChloroquineDrug

    • Chloroquine + Primaquine: Chloroquine 10, 10, 5 and Primaquine 0.5 mg/kg daily for 14 days
Study groups in NCT01640574
Study groupRoleWhat they receive
DHA-P 7 daysExperimentalDihydroartemisinin-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
Receives: Drug: Dihydroartemisinin-Piperaquine
DHA-P 14 daysExperimentalDihydroartemisinin-piperaquine + Primaquine: DHA-P 7mg/kg/day dihydroartemisinin and 55mg/kg/day piperaquine daily for 3 days Primaquine 0.5 mg/kg daily for 14 days
Receives: Drug: Dihydroartemisinin-Piperaquine
Chloroquine 7 daysActive comparatorChloroquine + Primaquine: Chloroquine 10, 10, 5 and Primaquine 1 mg/kg once daily for 7 days
Receives: Drug: Chloroquine
Chloroquine 14 daysActive comparatorChloroquine + Primaquine: Chloroquine 10, 10, 5 and Primaquine 0.5 mg/kg daily for 14 days
Receives: Drug: Chloroquine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recurrence of P. vivax

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

    Measured: 52 weeks

Secondary outcomes (3)

  1. Adverse Events

    Number of adverse events within 28 days of study medication

    Measured: 28 days

  2. Recurrence of P. vivax

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

    Measured: 6 months

  3. Drug concentrations

    Chloroquine, piperaquine and primaquine drug levels

    Measured: 63 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2012 (estimated)
  2. Study startFeb 2012
  3. Primary completionJul 2015
  4. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
680 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01640574
Sponsor's protocol ID
SMRU1102
Status last verified
Apr 2016
First submitted
11 Jul 2012
Last updated
28 Apr 2016
Results posted
No
Data monitoring committee
No

Publications

  • Stadler E, Cromer D, Mehra S, Adekunle AI, Flegg JA, Anstey NM, Watson JA, Chu CS, Mueller I, Robinson LJ, Schlub TE, Davenport MP, Khoury DS. Population heterogeneity in Plasmodium vivax relapse risk. PLoS Negl Trop Dis. 2022 Dec 19;16(12):e0010990. doi: 10.1371/journal.pntd.0010990. eCollection 2022 Dec.

    PubMed 36534705

  • Chu CS, Watson JA, Phyo AP, Win HH, Yotyingaphiram W, Thinraow S, Soe NL, Aung AA, Wilaisrisak P, Kraft K, Imwong M, Hanpithakpong W, Blessborn D, Tarning J, Proux S, Ling C, Nosten FH, White NJ. Determinants of Primaquine and Carboxyprimaquine Exposures in Children and Adults with Plasmodium vivax Malaria. Antimicrob Agents Chemother. 2021 Oct 18;65(11):e0130221. doi: 10.1128/AAC.01302-21. Epub 2021 Aug 16.

    PubMed 34398667

  • Chu CS, Phyo AP, Turner C, Win HH, Poe NP, Yotyingaphiram W, Thinraow S, Wilairisak P, Raksapraidee R, Carrara VI, Paw MK, Wiladphaingern J, Proux S, Bancone G, Sriprawat K, Lee SJ, Jeeyapant A, Watson J, Tarning J, Imwong M, Nosten F, White NJ. Chloroquine Versus Dihydroartemisinin-Piperaquine With Standard High-dose Primaquine Given Either for 7 Days or 14 Days in Plasmodium vivax Malaria. Clin Infect Dis. 2019 Apr 8;68(8):1311-1319. doi: 10.1093/cid/ciy735.

    PubMed 30952158

  • Chu CS, Bancone G, Moore KA, Win HH, Thitipanawan N, Po C, Chowwiwat N, Raksapraidee R, Wilairisak P, Phyo AP, Keereecharoen L, Proux S, Charunwatthana P, Nosten F, White NJ. Haemolysis in G6PD Heterozygous Females Treated with Primaquine for Plasmodium vivax Malaria: A Nested Cohort in a Trial of Radical Curative Regimens. PLoS Med. 2017 Feb 7;14(2):e1002224. doi: 10.1371/journal.pmed.1002224. eCollection 2017 Feb.

    PubMed 28170391

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dihydroartemisinin-Piperaquine and Chloroquine in people with Vivax Malaria, run by University of Oxford at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence of P. vivax (time frame: 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01640574, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2016; AzTrials last refreshed its copy on 7 Nov 2026.

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