Primaquine for Vivax Malaria in G6PD Intermediate and Deficient Cases.

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)

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Key information

Conditions

Vivax Malaria Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Carbohydrate Metabolism, Inborn Errors Congenital, Hereditary, and Neonatal Diseases and Abnormalities G6PD Deficiency Genetic Diseases, Inborn Glucosephosphate Dehydrogenase Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Infections Malaria Malaria, Vivax Metabolic Diseases Metabolism, Inborn Errors Mosquito-Borne Diseases Nutritional and Metabolic Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dr Marcus Lacerda, Manaus, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

• 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 criteria

• 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.

Treatment and study plan

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

Drug

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).

Drug

8 weekly Primaquine (0.75mg/kg dose).

Primary outcomes

Safety and efficacy of high dose primaquine

Time frame: 6 Months
- 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.
- To assess the safety and efficacy of weekly primaquine among patients who are g6Pd deficient (<30% activity)

Sponsors and collaborators

Lead sponsor

Menzies School of Health Research

Other

Collaborators

Arba Minch University
Curtin University
Indonesia University
Mahidol Oxford Tropical Medicine Research Unit
Oxford University Clinical Research Unit, Vietnam
Papua New Guinea Institute of Medical Research
University of Melbourne

Registry information

Important dates

Study start: 2024
Primary completion: 2028
Study completion: 2028
First posted: Mar 12, 2026
Registry last updated: Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed