Reducing the Risk of P. Vivax After Falciparum Infections in Co-endemic Areas
NCT03916003 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 500
Last updated 2023-11-21
Summary
This study is designed as a multi-centre randomized, open label trial to compare the safety and efficacy of a high dose primaquine (PQ) treatment in G6PD normal patients with P. falciparum to reduce the risk of subsequent P. vivax episodes to current standard practice of providing only schizontocidal treatment.
Conditions
- Malaria
- Vivax Malaria
- Falciparum Malaria
Interventions
- DRUG
-
primaquine
Primaquine regimen over 7 days (1.0 mg/kg/day for 7 days)
Sponsors & Collaborators
-
International Centre for Diarrhoeal Disease Research, Bangladesh
collaborator OTHER -
Tribhuvan University, Nepal
collaborator OTHER -
Arba Minch University
collaborator OTHER -
Addis Ababa University
collaborator OTHER -
Menzies School of Health Research
lead OTHER
Principal Investigators
-
Kamala Thriemer, MD · Menzies School of Health Research
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 1 Year
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-08-18
- Primary Completion
- 2022-05-14
- Completion
- 2022-07-30
Countries
- Bangladesh
- Ethiopia
- Indonesia
Study Locations
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