NCT07468513

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)

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
32mo left

Started May 2024

Longer than P75 for phase_4

Geographic Reach
3 countries

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress43%
May 2024Dec 2028

Study Start

First participant enrolled

May 17, 2024

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 12, 2026

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

March 12, 2026

Status Verified

November 1, 2025

Enrollment Period

4.1 years

First QC Date

January 27, 2026

Last Update Submit

March 9, 2026

Conditions

Vivax MalariaG6PD Deficiency

Keywords

Primaquine in G6PD deficiencyVivax malaria in G6PD deficient patients

Outcome Measures

Primary Outcomes (1)

  • Safety and efficacy of high dose primaquine

    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)

    6 Months

Study Arms (2)

Participants with G6PD intermediate status receive another active regimen appropriate for intermedia

ACTIVE COMPARATOR

G6PD activity 30-\<70%

Drug: 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

Participants withG6PD deficient status receive a specific treatment regimen appropriate for deficie

ACTIVE COMPARATOR

G6PD activity ≤30%

Drug: Patients with G6PD enzyme activities <30% of the AMM will be treated with schizontocidal treatment plus 8 weekly primaquine (0.75mg/kg dose).

Interventions

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 daysDRUG

Primaquine 1mg/kg/day for 7 days

Participants with G6PD intermediate status receive another active regimen appropriate for intermedia
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).

Participants withG6PD deficient status receive a specific treatment regimen appropriate for deficie

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Dr Marcus Lacerda

Manaus, Brazil

RECRUITING

Arba Minch General Hospital

Arba Minch, Ethiopia

NOT YET RECRUITING

Dr Moses Laman and Dr Brioni Moore

Alexishafen, Madang Province, Papua New Guinea

RECRUITING

Papua New Guinea Institute of Medical Research

Port Moresby, Magang, Papua New Guinea

RECRUITING

MeSH Terms

Conditions

Malaria, VivaxGlucosephosphate Dehydrogenase Deficiency

Interventions

Primaquine

Condition Hierarchy (Ancestors)

MalariaProtozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne DiseasesAnemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCarbohydrate Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

AminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2026

First Posted

March 12, 2026

Study Start

May 17, 2024

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

March 12, 2026

Record last verified: 2025-11

Locations

BR(1)PA(2)ET(1)