Study on the Treatment of Vivax Malaria

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomised open label trial with follow up for 1 year. 660 adults and children above 6 months diagnosed with acute Plasmodium vivax will be randomised into 3 groups, either chloroquine, artesunate, or chloroquine/primaquine therapy. Participants will be screened on the day of inclusion then followed weekly for 8 visits and every 4 weeks until week 52. The primary objective of the study is to compare the efficacy of the WHO and Thai Ministry of Public Health recommended radical curative regimen of chloroquine and primaquine with the currently used monotherapy regimens of chloroquine and artesunate along the Thai-Burmese border.

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

Details

• Lead Sponsor: University of Oxford
• Collaborator: Mahidol University
• Treatments: Artemisinins; Artesunate; Chloroquine; Chloroquine diphosphate; Primaquine

Criteria

Inclusion Criteria:

• Adults and children > 6 months

• Weight > 7 kg for children

• Have not had primaquine since last Pv episode

• Participant (or parent/guardian if < 18 years old) is willing and able to give written informed consent

• Microscopic diagnosis of Plasmodium vivax mono-infection

• Ability (in the investigators opinion) and willingness of patient or parent/guardian to comply with all study requirements

Exclusion Criteria

• Allergy to artesunate, chloroquine or primaquine

• Severe malaria

• Patients with microscopic diagnosis of co-infection with Plasmodium falciparum

• Presence of any condition which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study

• Inability to tolerate oral medication

• Pregnancy

• Blood transfusion in the last 3 months

• Antimalarial in last 2 months