Short Course Radical Cure of P. Vivax Malaria in Nepal

• Status: Not yet recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed as a multicentre randomized, open label trial to assess the safety and efficacy of a low dose short course PQ treatment (3.5mg/kg total dose given over 7 days) in glucose-6-phosphate dehydrogenase (G6PD) normal patients with P.vivax and P falciparum to reduce the risk of subsequent P.vivax episodes.

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

Details

• Lead Sponsor: Menzies School of Health Research
• Collaborator: Tribhuvan University, Nepal
• Treatments: Primaquine

Criteria

Inclusion Criteria:

• P. falciparum and/or vivax infection

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

• Age >1 years

• G6PD normal by Rapid Diagnostic Test (RDT) as per national guidelines

• 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