Eight Week Primaquine Regimen for the Treatment of Vivax Malaria

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Plasmodium vivax represents a major health problem throughout the tropics. Outside Africa it accounts for over 50% of cases, affecting an estimated 70-80 million people per year. A substantial proportion of clinical cases are not caused by infective bites of Anopheles spp, but by activation of latent hypnozoites in the liver. These relapses may significantly impede development since each illness may result in 5-15 days of absence from work or school.

Primaquine(PQ) is the only drug available that eliminates hypnozoites, though its use is beset by clinical problems; it may precipitate haemolytic anaemia in individuals deficient in the blood enzyme glucose 6 phosphate dehydrogenase (G6PD). Without affordable G6PD testing, primaquine use is precluded. Evidence suggests, however, that a course of 8 weekly doses may be a safe and effective alternative to the traditional 14 day course of the drug. The aim of the proposed study, therefore, is to test whether 8 weekly doses of primaquine is as effective as the 14 day course at preventing relapse malaria, without the risk of hemolysis in G6PD deficient individuals.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gates Malaria Partnership; London School of Hygiene and Tropical Medicine
• Collaborator: HealthNet TPO
• Treatments: Primaquine

Criteria

Inclusion Criteria:

• Patients diagnosed with P. vivax parasitaemia

• Patients over 3 years

• Patients with G6PD deficiency to a safety trial

• Patients without G6PD deficiency to all other groups.

Exclusion Criteria:

• Children under the age of three

• Pregnant / breast feeding women

• Patients with severe clinical anaemia [Hb<7g/dl]

• Patients with P. falciparum

• Patients unavailable for the duration of study.

• Patients who have taken antimalarial drugs in the 2 weeks prior to consultation.

• Patients with concomitant infections or whose general health is considered too poor.