RECRUITINGPhase 4INTERVENTIONAL
Primaquine for Vivax Malaria in G6PD Intermediate and Deficient Cases.
About This Trial
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)
Who May Be Eligible (Plain English)
Who May Qualify:
- • 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 willing to sign a consent form
- Living in the study area and willing to be followed for six months.
Who Should NOT Join This Trial:
- • 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
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).
Locations (4)
Dr Marcus Lacerda
Manaus, Brazil
Arba Minch General Hospital
Arba Minch, Ethiopia
Dr Moses Laman and Dr Brioni Moore
Alexishafen, Madang Province, Papua New Guinea
Papua New Guinea Institute of Medical Research
Port Moresby, Magang, Papua New Guinea