Primaquine for Vivax Malaria in G6PD Intermediate and Deficient Cases.
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• • 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.
Locations
Other Locations
Brazil
Dr Marcus Lacerda
RECRUITING
Manaus
Ethiopia
Arba Minch General Hospital
NOT_YET_RECRUITING
Arba Minch
Papua New Guinea
Dr Moses Laman and Dr Brioni Moore
RECRUITING
Alexishafen
Papua New Guinea Institute of Medical Research
RECRUITING
Port Moresby
Time Frame
Start Date: 2024-05-17
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 100
Treatments
Active_comparator: Participants with G6PD intermediate status receive another active regimen appropriate for intermedia
G6PD activity 30-\<70%
Active_comparator: Participants withG6PD deficient status receive a specific treatment regimen appropriate for deficie
G6PD activity ≤30%
Related Therapeutic Areas
Sponsors
Collaborators: Papua New Guinea Institute of Medical Research, Curtin University, Arba Minch University, Indonesia University, Oxford University Clinical Research Unit, Vietnam, University of Melbourne, Mahidol Oxford Tropical Medicine Research Unit
Leads: Menzies School of Health Research