Investigation of Short Course, High Dose Primaquine Treatment for Liver Stages of Plasmodium Vivax Infection
NCT ID: NCT02364583
Last Updated: 2015-10-14
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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UNKNOWN
PHASE4
150 participants
INTERVENTIONAL
2010-06-30
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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14 day dose regimen
0.5 mg/kg oral Primaquine administered daily for 14 days
Primaquine
Primaquine treatment given in a step-wise manner; (a) 0.5 mg/kg total dose daily for 14 days (n=40), (b) 1.0 mg/kg total dose daily for 7 days (n=40), (c) 1.0 mg/kg twice daily for 3.5 days (n=40)
7 day dose regimen
1.0 mg/kg oral Primaquine administered daily for 7 days
Primaquine
Primaquine treatment given in a step-wise manner; (a) 0.5 mg/kg total dose daily for 14 days (n=40), (b) 1.0 mg/kg total dose daily for 7 days (n=40), (c) 1.0 mg/kg twice daily for 3.5 days (n=40)
3.5 day dose regimen
1.0 mg/kg oral Primaquine administered twice daily (bd) for 3.5 days
Primaquine
Primaquine treatment given in a step-wise manner; (a) 0.5 mg/kg total dose daily for 14 days (n=40), (b) 1.0 mg/kg total dose daily for 7 days (n=40), (c) 1.0 mg/kg twice daily for 3.5 days (n=40)
Interventions
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Primaquine
Primaquine treatment given in a step-wise manner; (a) 0.5 mg/kg total dose daily for 14 days (n=40), (b) 1.0 mg/kg total dose daily for 7 days (n=40), (c) 1.0 mg/kg twice daily for 3.5 days (n=40)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Absence of history of hypersensitivity reactions to pre-treatment drugs
* Positive for P. vivax infections on blood smear or PCR
* Normal G6PD enzyme activity
Exclusion Criteria
* Clinical evidence of nonmalarial illness
* Severe malnutrition (weight for age nutritional Z score \<60th percentile)
* Moderate to severe anemia (Hb \<8g/dL)
* Permanent disability which prevents or impedes study participation
5 Years
10 Years
ALL
No
Sponsors
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Walter and Eliza Hall Institute of Medical Research
OTHER
The University of Western Australia
OTHER
University of Oxford
OTHER
Curtin University
OTHER
Papua New Guinea Institute of Medical Research
OTHER_GOV
Responsible Party
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Principal Investigators
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Inoni Betuela, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
PNG Institute of Medical Research
Ivo Mueller, PhD
Role: PRINCIPAL_INVESTIGATOR
Walter and Eliza Hall Institute of Medical Research; Centre de Recerca en Salut Internacional de Barcelona (CRESIB)
J Kevin Baird, PhD
Role: PRINCIPAL_INVESTIGATOR
Eijkman-Oxford Clinical Research Unit, Oxford University
Timothy ME Davis, FRAC, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Western Australia
Locations
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PNG Institute of Medical Research
Madang, Madang Province, Papua New Guinea
Countries
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Central Contacts
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Facility Contacts
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References
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Moore BR, Salman S, Tobe R, Benjamin J, Yadi G, Kasian B, Laman M, Robinson LJ, Page-Sharp M, Betuela I, Batty KT, Manning L, Mueller I, Davis TME. Short-course, high-dose primaquine regimens for the treatment of liver-stage vivax malaria in children. Int J Infect Dis. 2023 Sep;134:114-122. doi: 10.1016/j.ijid.2023.05.063. Epub 2023 Jun 1.
Other Identifiers
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MRAC10.14
Identifier Type: -
Identifier Source: org_study_id
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