Surveillance and Treatment With Dihydroartemisinin-piperaquine Plus Primaquine

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Mass Drug Administration (MDA) and Mass Screening and Selective Treatment (MST) might be applied as strategies for eliminating malaria when focusing on transmission stages. Many studies either with MDA or MST has been done in low transmission areas demonstrated the impact of those activities to reduce malaria transmission. However, in high transmission such study is still very limited which is becoming the reason behind this study.

A randomized cluster trial of MST study using dihydroartemisinin-piperaquine plus primaquine (DHP + PQ) will be conducted in some villages at the Belu regency, Nusa Tenggara TImur province, Central Indonesia. There will be three arms in the study, i.e. (1) intervention arm of mass screening and treatment with interval of 6 weeks; (2) intervention arm of mass screening and treatment with interval of 3 months and (3) control arm without mass screening and treatment. The intervention arm with 6 weeks interval represents a new proposed method to detection malaria infections, while the intervention arm with 3 month interval represents the Ministry of Health current policy of active case detection in Indonesia, and the third arm will serve as the control for Ministry of Health's policy.

The study will be conducted in 6 months period and evaluate various parameters including malaria incidence and proportion of anemia in monthly cohort school children (in arm1, 2 and 3), in addition to malaria prevalence in the community (only in arm 1 and arm 2). All positive subject in all arms will receive supervised treatment. Secondary objectives are the proportion of gametocytemia in the community, the proportion of malaria antibody of various age groups, population genetic of local parasite, submicroscopic incidence based polymerase chain reaction and the proportion of infective mosquitoes. Data analysis will be performed according to the method for cluster randomized trial evaluation.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Indonesia University
• Collaborator: Walter and Eliza Hall Institute of Medical Research
• Treatments: Artemisinins; Artenimol; Dihydroartemisinin; Piperaquine; Primaquine

Criteria

Inclusion Criteria:

• All villagers of the all selected clusters

Exclusion Criteria:

• Pregnant women during their first trimester

• Single dose primaquine should not be given for infants less than 1 year-old, pregnant women in all trimesters of pregnancy, breast-feeding mother and patients with G6PD deficiency