Primaquine for Vivax Malaria in G6PD Intermediate and Deficient Cases.
Recruiting
Phase 4Interventional Study
Vivax MalariaG6PD Deficiency
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
100 (estimated)
Sponsor
Menzies School of Health Research · Other
Who this trial is looking for
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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 Locations
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City
State
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Status
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 …
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.
Contacts
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