Primaquine for Vivax Malaria in G6PD Intermediate and Deficient Cases.

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07468513

Enrollment

100

Registered

2026-03-12

Start date

2024-05-17

Completion date

2028-12-31

Last updated

2026-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

G6PD Deficiency, Vivax Malaria

Keywords

Primaquine in G6PD deficiency, Vivax malaria in G6PD deficient patients

Brief 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)

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).

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Safety and efficacy of high dose primaquine	6 Months	1. 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. 2. To assess the safety and efficacy of weekly primaquine among patients who are g6Pd deficient (\<30% activity)

Countries

Brazil, Ethiopia, Papua New Guinea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026