NCT02793388

A Trial on Supervised Primaquine Use in Ethiopia

A Randomized Controlled Trial on Supervised Primaquine Use in Ethiopia

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Menzies School of Health Research · Academic / Other
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Malaria

Interventions

Type	Name	Description
DRUG	Supervised primaquine treatment	Following schizontocidal treatment malaria patients (P. falciparum and P. vivax) will receive 14days primaquine treatment if found to be G6PD normal. Primaquine treatment is provided supervised every other day.
DRUG	Unsupervised primaquine treatment	Following schizontocidal treatment malaria patients (P. falciparum and P. vivax) will receive 14days primaquine treatment if found to be G6PD normal. Primaquine treatment is provided unsupervised.

Timeline

• Start date: 2016-09-01
• Primary completion: 2017-09-01
• Completion: 2017-09-01
• First posted: 2016-06-08
• Last updated: 2017-02-08