Menu
Recruiting NCT07468513

Primaquine for Vivax Malaria in G6PD Intermediate and Deficient Cases.

Phase IV Interventional Vivax Malaria G6PD Deficiency

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 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, Patients with G6PD enzyme activities <30% of the AMM will be treated with schizontocidal treatment plus 8 weekly primaquine (0.75mg/kg dose)..
Who it may be relevant to
Registry conditions: Vivax Malaria, G6PD Deficiency. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil, Ethiopia, Papua New Guinea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • 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
    Primaquine 1mg/kg/day for 7 days
  • Drug Patients 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).

Primary outcome measures

  • Safety and efficacy of high dose primaquine [Time frame: 6 Months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Papua New Guinea · 2 centers
  • Dr Moses Laman and Dr Brioni Moore — Alexishafen
  • Papua New Guinea Institute of Medical Research — Port Moresby
Brazil · 1 center
  • Dr Marcus Lacerda — Manaus
Ethiopia · 1 center
  • Arba Minch General Hospital — Arba Minch

Identifiers

NCT: NCT07468513 · HREC 24-4988

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗