Primaquine for Vivax Malaria in G6PD Intermediate and Deficient Cases.

Phase 4RecruitingNCT07468513

Menzies School of Health Research100 enrolled

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)

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Vivax Malaria G6PD Deficiency

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

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).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (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

Outcomes

Primary Outcomes

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)

Time frame: 6 Months

Data from ClinicalTrials.gov

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