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Plasmodium Vivax InfectionPhase 4NCT02143934

Effect of Liver and Blood-stage Treatment on Subsequent Plasmodium Reinfection and Morbidity

A Phase 4 study testing Primaquine, Chloroquine and Artemether Lumefantrine in people with Plasmodium Vivax Infection and Plasmodium Vivax Clinical Episode, run by Papua New Guinea Institute of Medical Research at 1 site in Papua New Guinea.

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 study specifically seeks to quantify the contribution of relapes to the burden of P. vivax infections and disease by determining on the effect of radical pre-erythrocytic and erythrocytic clearance on subsequent rates of Plasmodium spp. Read more about this study

Who is it for?
Ages 5 to 10 yearsHealthy volunteers can take part
What is being tested?
Primaquine, Chloroquine and Artemether Lumefantrine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
524 participants
Where
1 sitePapua New Guinea
Study dates
Aug 2009to May 2014
Phase
Phase 4
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 5 to 10 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • aged 5-10 years (±3 months)
  • permanent residents of the area
  • absence of history of hypersensitivity reactions to the drugs

Who cannot join

  • chronic illness
  • severe malnutrition (weight-for-age nutritional Z score [WAZ] <60th percentile)
  • severe anemia (Hb <5 g/dL),
  • G-6-PD deficiency (<60% G-6-PD activity)
  • permanent disability, which prevents or impedes study participation. Any 1 or more of the criteria is sufficient to exclude study participation.

Trial locations and contacts

1 site in 1 country.

Papua New Guinea1 site

  • PNG Institute of Medical Research

    Maprik, East Sepik Province

Other trials in Papua New Guinea

About this study

Official title: Host and Parasites Factors Contributing to Risk of Plasmodium Re-infection and Morbidity in Elementary School Children in Maprik, East Sepik Province

This study specifically seeks to quantify the contribution of relapes to the burden of P. vivax infections and disease by determining on the effect of radical pre-erythrocytic and erythrocytic clearance on subsequent rates of Plasmodium spp. infection and disease in children aged 5-10 years in a treatment to re-infection study design. In order the clear liver-stage/blood-stages G6PD-normal children were randomised to receive Chloroquine (3 days, standard dose) and Coartem (3 days, standard dose) plus either i) primaquine (20 days, 0.5mg/kg) or ii) placebo (20days). These drugs were administered over a period of 4 weeks.

In addition to this epidemiological data, the study will assess the natural acquisition of cellular and humoral immune responses to P. falciparum and P. vivax, thus assisting in the determination of correlates of clinical immunity to P. falciparum and P. vivax in PNG children aged 5-10 years.

These data will not only be essential for development of future vaccines against P. vivax and P falciparum but provide invaluable insight into the contribution of long-lasting liver-stages to the force of infection with P. vivax that will contribute towards designing more rational approaches to the treatment of P. vivax both in the context of case management and future attempts at elimination.

Being tested
Primaquine, Placebo, Chloroquine, Artemether Lumefantrine
Keywords
Plasmodium vivax, Hypnozoites, Primaquine, Liver-stage, Blood-stage, Plasmodium falciparum
Medical subject headings
Malaria, Vivax, Malaria, Falciparum

What participants receive

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

  • PrimaquineDrug

  • PlaceboDrug

    Sugar pills, appearance identical to Primaquine tablets

  • ChloroquineDrug

  • Artemether LumefantrineDrug

    Also called Coartem

Study groups in NCT02143934
Study groupRoleWhat they receive
PrimaquineActive comparatorPrimaquine, 0.5mg/kg/day, 20 days directly observed treatment Chloroquine, 25mg/kg total dose, divided over 3 days directly observed treatment Artemether-Lumefantrine, 3 days BD
Receives: Drug: Primaquine; Drug: Chloroquine; Drug: Artemether Lumefantrine
PlaceboPlacebo comparatorPlacebo, 20 days directly observed treatment Chloroquine, mg/kg, 3 days directly observed treatment Artemether-Lumefantrine, 3 days BD
Receives: Drug: Placebo; Drug: Chloroquine; Drug: Artemether Lumefantrine

What is being measured

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

  1. Time to first or only Plasmodium vivax infection by light microscopy and PCR

    Measured: 8 months post-baseline

  2. Time to first or only clinical P. vivax episode

    Measured: 8 months post-baseline

Secondary outcomes (3)

  1. Time to first or only P. falciparum infection by light microscopy and PCR

    Measured: 8 months post-baseline

  2. Time to first or only P. ovale infection by light microscopy and PCR

    Measured: 8 months post-baseline

  3. Time to first or only P. malariae infection by light microscopy and PCR

    Measured: 8 months post-baseline

Timeline

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

  1. First posted21 May 2014 (estimated)
  2. Study startAug 2009
  3. Primary completionMay 2010
  4. Study completionMay 2014

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 4
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
524 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02143934
Sponsor's protocol ID
07200734
Status last verified
May 2014
First submitted
19 May 2014
Last updated
21 May 2014
Results posted
No
Data monitoring committee
No

Publications

  • Potter GE, Callier V, Shrestha B, Joshi S, Dwivedi A, Silva JC, Laurens MB, Follmann DA, Deye GA. Can incorporating genotyping data into efficacy estimators improve efficiency of early phase malaria vaccine trials? Malar J. 2023 Dec 19;22(1):383. doi: 10.1186/s12936-023-04802-0.

    PubMed 38115002

  • Potter GE, Callier V, Shrestha B, Joshi S, Dwivedi A, Silva JC, Laurens MB, Follmann DA, Deye GA. Can incorporating genotyping data into efficacy estimators improve efficiency of early phase malaria vaccine trials? Res Sq [Preprint]. 2023 Sep 22:rs.3.rs-3370731. doi: 10.21203/rs.3.rs-3370731/v1.

    PubMed 37790581

  • 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

  • Holzschuh A, Gruenberg M, Hofmann NE, Wampfler R, Kiniboro B, Robinson LJ, Mueller I, Felger I, White MT. Co-infection of the four major Plasmodium species: Effects on densities and gametocyte carriage. PLoS Negl Trop Dis. 2022 Sep 13;16(9):e0010760. doi: 10.1371/journal.pntd.0010760. eCollection 2022 Sep.

    PubMed 36099312

  • Hofmann NE, Karl S, Wampfler R, Kiniboro B, Teliki A, Iga J, Waltmann A, Betuela I, Felger I, Robinson LJ, Mueller I. The complex relationship of exposure to new Plasmodium infections and incidence of clinical malaria in Papua New Guinea. Elife. 2017 Sep 1;6:e23708. doi: 10.7554/eLife.23708.

    PubMed 28862132

  • Wampfler R, Hofmann NE, Karl S, Betuela I, Kinboro B, Lorry L, Silkey M, Robinson LJ, Mueller I, Felger I. Effects of liver-stage clearance by Primaquine on gametocyte carriage of Plasmodium vivax and P. falciparum. PLoS Negl Trop Dis. 2017 Jul 21;11(7):e0005753. doi: 10.1371/journal.pntd.0005753. eCollection 2017 Jul.

    PubMed 28732068

  • Robinson LJ, Wampfler R, Betuela I, Karl S, White MT, Li Wai Suen CS, Hofmann NE, Kinboro B, Waltmann A, Brewster J, Lorry L, Tarongka N, Samol L, Silkey M, Bassat Q, Siba PM, Schofield L, Felger I, Mueller I. Strategies for understanding and reducing the Plasmodium vivax and Plasmodium ovale hypnozoite reservoir in Papua New Guinean children: a randomised placebo-controlled trial and mathematical model. PLoS Med. 2015 Oct 27;12(10):e1001891. doi: 10.1371/journal.pmed.1001891. eCollection 2015 Oct.

    PubMed 26505753

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Primaquine, Chloroquine and Artemether Lumefantrine in people with Plasmodium Vivax Infection and Plasmodium Vivax Clinical Episode, run by Papua New Guinea Institute of Medical Research at 1 site in Papua New Guinea.

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 3 inclusion and 5 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 21 May 2014. 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 Papua New Guinea. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Time to first or only Plasmodium vivax infection by light microscopy and PCR (time frame: 8 months post-baseline). The study lists 2 primary outcomes in all. 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 NCT02143934, which also lists 7 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 21 May 2014.

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