Effect of Liver and Blood-stage Treatment on Subsequent Plasmodium Reinfection and Morbidity
NCT ID: NCT02143934
Last Updated: 2014-05-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
524 participants
INTERVENTIONAL
2009-08-31
2014-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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Primaquine
Primaquine, 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
Primaquine
Chloroquine
Artemether Lumefantrine
Placebo
Placebo, 20 days directly observed treatment Chloroquine, mg/kg, 3 days directly observed treatment Artemether-Lumefantrine, 3 days BD
Placebo
Sugar pills, appearance identical to Primaquine tablets
Chloroquine
Artemether Lumefantrine
Interventions
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Primaquine
Placebo
Sugar pills, appearance identical to Primaquine tablets
Chloroquine
Artemether Lumefantrine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* permanent residents of the area
* absence of history of hypersensitivity reactions to the drugs
Exclusion Criteria
* 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.
5 Years
10 Years
ALL
Yes
Sponsors
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Walter and Eliza Hall Institute of Medical Research
OTHER
Swiss Tropical & Public Health Institute
OTHER
Barcelona Centre for International Health Research
OTHER
Papua New Guinea Institute of Medical Research
OTHER_GOV
Responsible Party
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Principal Investigators
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Ivo Mueller, PhD
Role: PRINCIPAL_INVESTIGATOR
Walter and Eliza Hall Institute of Medical Research; Centre de Recerca en Salut Internacional de Barcelona (CRESIB)
Inoni Betuela, MD PhD
Role: PRINCIPAL_INVESTIGATOR
PNG Institute of Medical Research
Louis Schofield, PhD
Role: PRINCIPAL_INVESTIGATOR
Walter and Eliza Hall Institute of Medical Research
Locations
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PNG Institute of Medical Research
Maprik, East Sepik Province, Papua New Guinea
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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07200734
Identifier Type: -
Identifier Source: org_study_id
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