A Trial on Supervised Primaquine Use in Ethiopia

• Status: Withdrawn
• Trial end date: 2017-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, controlled, open label trial to assess the effectiveness of unsupervised versus supervised primaquine treatment in patients with uncomplicated malaria. In co-endemic regions, the risk of P. vivax relapse following treatment for P. falciparum is high. Hence patients infected with either P. vivax or P. falciparum will be included in the study. The study will be conducted in Ethiopia. Participants will be enrolled at health centres and provided with the recommended schizontocidal treatment plus primaquine radical cure which will be either supervised or unsupervised according to randomisation. Participants will be followed up for four months and assessed at regular intervals for the presence of patent and sub-patent malaria. The outcome of the study will contribute to an improved treatment scheme for uncomplicated malaria in this area.

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

Details

• Lead Sponsor: Menzies School of Health Research
• Collaborator: Armauer Hansen Research Institute, Ethiopia
• Treatments: Polystyrene sulfonic acid; Primaquine

Criteria

Inclusion Criteria:

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

• Age >5 years

• Weight >5kg

• Written informed consent

• Living in the study area and willing to be followed for 4 months

Exclusion Criteria:

• General danger signs or symptoms of severe malaria (Appendix 17.1 and 17.2)

• 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

• Living in the same household as an individual enrolled into the study in the last 14 days