NCT07468513 Primaquine for Vivax Malaria in G6PD Intermediate and Deficient Cases.
| NCT ID | NCT07468513 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Menzies School of Health Research |
| Condition | Vivax Malaria |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-05-17 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 100 participants in total. It began in 2024-05-17 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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)
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.
Frequently Asked Questions
Who can join the NCT07468513 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Vivax Malaria. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07468513 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07468513 currently recruiting?
Yes, NCT07468513 is actively recruiting participants. Visit ClinicalTrials.gov or contact Menzies School of Health Research to inquire about joining.
Where is the NCT07468513 trial being conducted?
This trial is being conducted at Manaus, Brazil, Arba Minch, Ethiopia, Alexishafen, Papua New Guinea, Port Moresby, Papua New Guinea.
Who is sponsoring the NCT07468513 clinical trial?
NCT07468513 is sponsored by Menzies School of Health Research. The trial plans to enroll 100 participants.