Primaquine for Vivax Malaria in G6PD Intermediate and Deficient Cases.
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMenzies School of Health Research
About this trial
A non randomized observation study that is aiming to assess the safety and efficacy of high dose primaquine (1mg/kg per day over 7 days) among patients with intermediate (30-70%) G6PD activity and the safety and efficacy of weekly primaquine among patients who are g6Pd deficient (\<30% activity)
Eligibility criteria
Qualifiers
• P. vivax peripheral parasitaemia (mono-infection)
G6PD intermediate or deficient status (G6PD activity 30-<70% or ≤30% of the adjusted male median as determined by the Standard G6PD (SDBioline, ROK))
Fever (temperature ≥37.5⁰C) or history of fever in the preceding 48 hours
Age ≥18 years
Disqualifiers
• Danger signs or symptoms of severe malaria
Pregnant or lactating females
Regular use of drugs with haemolytic potential
Known hypersensitivity to any of the study drugs.
Trial design
Treatments tested in this trial
- Patients with G6PD enzyme activities between 30 and <70% of the AMM will be treated with schizontocidal treatment plus high dose primaquine 1mg/kg/day for 7 days
- Patients with G6PD enzyme activities <30% of the AMM will be treated with schizontocidal treatment plus 8 weekly primaquine (0.75mg/kg dose).
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Menzies School of Health Research
Lead sponsor
Curtin University
Collaborator
University of Melbourne
Collaborator
Arba Minch University
Collaborator
Papua New Guinea Institute of Medical Research
Collaborator
Mahidol Oxford Tropical Medicine Research Unit
Collaborator
Oxford University Clinical Research Unit, Vietnam
Collaborator
Indonesia University
Collaborator
Source ClinicalTrials.gov