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New treatment option for Vivax Malaria
Official title Primaquine for Vivax Malaria in G6PD Intermediate and Deficient Cases.
ClinicalTrials.gov ID: NCT07468513
What this study is testing
What is 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 between 30 and <70% of the AMM will be treated with schizontocidal treatment plus high dose primaquine 1mg/kg/day for 7 days is an investigational medicine, given as an once-weekly, being studied as a potential treatment for vivax malaria.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely can't join 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Manaus, Brazil
- Arba Minch, Ethiopia
- Alexishafen, Madang Province, Papua New Guinea
- Port Moresby, Magang, Papua New Guinea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Manaus, Brazil; Arba Minch, Ethiopia; Alexishafen, Madang Province, Papua New Guinea; Port Moresby, Magang, Papua New Guinea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.