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Vivax MalariaPhase 3VHXNCT01074905

Study on the Treatment of Vivax Malaria

A Phase 3 study testing Artesunate, Chloroquine and Chloroquine/Primaquine 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

This is a randomised open label trial with follow up for 1 year. 660 adults and children above 6 months diagnosed with acute Plasmodium vivax will be randomised into 3 groups, either chloroquine, artesunate, or chloroquine/primaquine therapy. 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?
Artesunate, Chloroquine and Chloroquine/Primaquine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
655 participants
Where
1 siteThailand
Study dates
May 2010to Oct 2012
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

  • Adults and children > 6 months
  • Weight > 7 kg for children
  • Have not had primaquine since last Pv episode
  • Participant (or parent/guardian if < 18 years old) is willing and able to give written informed consent
  • Microscopic diagnosis of Plasmodium vivax mono-infection
  • Ability (in the investigators opinion) and willingness of patient or parent/guardian to comply with all study requirements

Who cannot join

  • Allergy to artesunate, chloroquine or primaquine
  • Severe malaria
  • Patients with microscopic diagnosis of co-infection with Plasmodium falciparum
  • 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
  • Inability to tolerate oral medication
  • Pregnancy
  • Blood transfusion in the last 3 months
  • Antimalarial in last 2 months

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • Shoklo Malaria Research Unit

    Mae Sot

Other trials in Thailand

About this study

Official title: A Randomised Open Label Study Comparing the Efficacy of Chloroquine/Primaquine, Chloroquine and Artesunate in the Treatment of Vivax Malaria Along the Thai-Burmese Border

This is a randomised open label trial with follow up for 1 year. 660 adults and children above 6 months diagnosed with acute Plasmodium vivax will be randomised into 3 groups, either chloroquine, artesunate, or chloroquine/primaquine therapy. Participants will be screened on the day of inclusion then followed weekly for 8 visits and every 4 weeks until week 52. The primary objective of the study is to compare the efficacy of the WHO and Thai Ministry of Public Health recommended radical curative regimen of chloroquine and primaquine with the currently used monotherapy regimens of chloroquine and artesunate along the Thai-Burmese border.

Read the detailed description

Considerably less attention has been paid to Plasmodium vivax epidemiology than Plasmodium falciparum. In areas of relatively low unstable transmission, which comprise the majority of P.vivax affected areas, vivax malaria is predominantly a disease of children (Luxemburger et al 1999). Chloroquine has long been the standard treatment for vivax malaria. Primaquine is recommended for radical cure of vivax malaria, but is difficult to administer due to dosing duration and side effects.

This study aims to characterize the epidemiologic history comparing the efficacy of 3 antimalarial regimens (chloroquine, artesunate, and chloroquine/primaquine) for plasmodium vivax in western Thailand. Chloroquine is currently the standard of treatment for Plasmodium vivax. Due to the long half-life or chloroquine, the first relapse of vivax malaria may be delayed. In contrast, artesunate has a very short half-life, thus, having no impact on first relapse. It is not known whether chloroquine reduces the overall number of relapses, or only delays the first relapse. There are many important questions about the biology of vivax malaria of relevance to treatment that remain unanswered. For example is the number of relapses per infection (i.e. per successful inoculation) predetermined or adaptive? If it is predetermined then suppression of the first relapse (as with chloroquine, mefloquine or piperaquine) will reduce the total number of relapses and this is a clear benefit. If it is adaptive then these drugs will simply delay the relapses and there is less clear benefit. These various uncertainties illustrate the importance of detailed comparative longitudinal evaluations. In order to characterize the biology of vivax malaria, it will be necessary to compare regimens with and without primaquine. Because of the challenges that face primaquine prescription (side effects, toxicity in G6PD deficient patients and duration of treatment), it is not commonly deployed along the Thai Burma border. In effect, we will be comparing usual practice (non primaquine regimens) with the recommended WHO and Thai MOPH practice (use of primaquine for 14 days). The information we will gather is crucial to the understanding of chloroquine and its effect on the vivax parasite. This will lead to future studies and invariably change the way we treat vivax malaria.

Conditions
Vivax Malaria
Being tested
Artesunate, Chloroquine, Chloroquine/Primaquine
Keywords
vivax malaria, artesunate, chloroquine, primaquine, relapse
Medical subject headings
Malaria, Vivax, Recurrence

What participants receive

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

  • ArtesunateDrug

    2 mg/kg/day as single daily dose given for 5 days; maximum dose range is 1.6 to 2.4 mg/kg/day or a total of 8 to 12 mg/kg.

  • ChloroquineDrug

    25 mg base/kg given in divided doses (10,10,5) over 3 days; Absolute range 20-30 mg/kg.

  • Chloroquine/PrimaquineDrug

    Chloroquine 3 days and Primaquine 14 days

Study groups in NCT01074905
Study groupRoleWhat they receive
ArtesunateActive comparator2 mg/kg/day as single daily dose given for 5 days; maximum dose range is 1.6 to 2.4 mg/kg/day or a total of 8 to 12 mg/kg.
Receives: Drug: Artesunate
ChloroquineActive comparator25 mg base/kg given in divided doses (10,10,5) over 3 days; Absolute range 20-30 mg/kg.
Receives: Drug: Chloroquine
Chloroquine/PrimaquineExperimentalChloroquine 3 days and Primaquine 14 days
Receives: Drug: Chloroquine/Primaquine

What is being measured

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

  1. The first recurrence of Plasmodium vivax malaria

    The first recurrence of Plasmodium vivax malaria within 28 days

    Measured: Day 28

Secondary outcomes (5)

  1. Any recurrence of Plasmodium vivax parasitemia

    Any recurrence of Plasmodium vivax parasitemia within the follow up period

    Measured: 1 year

  2. Time to first recurrence, median time between episodes of vivax infections and total number of episodes

    Time to first recurrence, median time between episodes of vivax infections and total number of episodes in the follow up period

    Measured: 1 year

  3. Overall number of days of illness and haematocrit below 30%

    Overall number of days of illness and haematocrit below 30% within the follow up period

    Measured: 1 year

  4. Chloroquine level

    Whole blood chloroquine level at day 7 and any day of recurrence of Plasmodium vivax malaria

    Measured: Day 7

  5. Adverse events

    Adverse event profiles of artesunate, chloroquine and primaquine

    Measured: 1 year

Timeline

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

  1. First posted24 Feb 2010 (estimated)
  2. Study startMay 2010
  3. Primary completionOct 2012
  4. Study completionOct 2012

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
655 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01074905
Sponsor's protocol ID
SMRU0908
Acronym
VHX
Status last verified
Aug 2013
First submitted
23 Feb 2010
Last updated
28 Aug 2013
Results posted
No
Data monitoring committee
Yes

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, Phyo AP, Lwin KM, Win HH, San T, Aung AA, Raksapraidee R, Carrara VI, Bancone G, Watson J, Moore KA, Wiladphaingern J, Proux S, Sriprawat K, Winterberg M, Cheah PY, Chue AL, Tarning J, Imwong M, Nosten F, White NJ. Comparison of the Cumulative Efficacy and Safety of Chloroquine, Artesunate, and Chloroquine-Primaquine in Plasmodium vivax Malaria. Clin Infect Dis. 2018 Oct 30;67(10):1543-1549. doi: 10.1093/cid/ciy319.

    PubMed 29889239

  • Pratt B, Zion D, Lwin KM, Cheah PY, Nosten F, Loff B. Closing the translation gap for justice requirements in international research. J Med Ethics. 2012 Sep;38(9):552-8. doi: 10.1136/medethics-2011-100301. Epub 2012 Mar 16.

    PubMed 22427705

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Artesunate, Chloroquine and Chloroquine/Primaquine 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 6 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 Aug 2013. 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?

The first recurrence of Plasmodium vivax malaria (time frame: Day 28). 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 NCT01074905, which also lists 3 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 Aug 2013.

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