RecruitingPhase 4NCT07468513
Primaquine for Vivax Malaria in G6PD Intermediate and Deficient Cases.
Sponsor
Menzies School of Health Research
Enrollment
100 participants
Start Date
May 17, 2024
Study Type
INTERVENTIONAL
Summary
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
Min Age: 18 Years
Inclusion Criteria7
- 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
- Haemoglobin at presentation ≥8g/dl
- Written informed consent
- Living in the study area and willing to be followed for six months.
Exclusion Criteria4
- 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.
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Interventions
DRUGPatients 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
Primaquine 1mg/kg/day for 7 days
DRUGPatients with G6PD enzyme activities <30% of the AMM will be treated with schizontocidal treatment plus 8 weekly primaquine (0.75mg/kg dose).
8 weekly Primaquine (0.75mg/kg dose).
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07468513