Reducing the Risk of P. Vivax After Falciparum Infections in Co-endemic Areas

• Status: Recruiting
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed as a multi-centre randomized, open label trial to compare the safety and efficacy of a high dose primaquine (PQ) treatment in G6PD normal patients with P. falciparum to reduce the risk of subsequent P. vivax episodes to current standard practice of providing only schizontocidal treatment.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Menzies School of Health Research
• Collaborators: Addis Ababa University; Arba Minch University; Arba Minch University, Ethiopia; International Centre for Diarrhoeal Disease Research, Bangladesh; Tribhuvan University, Nepal
• Treatments: Primaquine

Criteria

Inclusion Criteria:

• P. falciparum mono-infection

• Fever (axillary temperature ≥37.5⁰C) or history of fever in preceding 48 hours

• Age >1 years

• G6PD normal as defined by the Biosensor (SD Biosensor, ROK) at ≥70% of the adjusted male median (AMM) for each site

• Written informed consent

• Able to comply with all study procedures and timelines

Exclusion Criteria:

• General danger signs or symptoms of severe malaria

• Anaemia, defined as Hb <8g/dl

• Pregnant women as determined by Urine β-HCG pregnancy test

• Breast feeding women

• Known hypersensitivity to any of the drugs given

• Regular use of drugs with haemolytic potential

• Blood transfusion within the last 4 months