NCT01389557

Impact of Dihydroartemisinin-piperaquine Plus Primaquine on Malaria Transmission in Lampung Province, Sumatra

Evaluation of Impact Dihydroartemisinin-piperaquine Plus Primaquine on Malaria Transmission in Lempasing Village, Lampung Province, Southern Sumatra

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Indonesia University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

Artemisinin-based combination therapy (ACT) has been known to be controversial for stopping malaria transmission. The addition of primaquine (PQ) - the only drug commercially available that kills mature transmission stage - to such treatments might be necessary to eliminate this stage. A study is conducted to evaluate the efficacy of dihydroartemisinin-piperaquine (DHP) regimens with PQ on malaria transmission on a community wide level in Lempasing, Lampung, Sumatra.

Detailed description

A mass screening baseline survey enabled the description of malaria prevalence (P. falciparum and P. vivax). Malaria infected asymptomatic (from the mass screening) and symptomatic (malaria infected people attending the health center) people were enrolled in the study. Enrolled malaria infected subjects were treated with DHP and PQ according to the treatment regimen. The community was mass screened for malaria infections every 3 months and an incidence cohort screened every month for infections. The 3 aims were to look at malaria antibodies, haemoglobin levels and the incidence of malaria before and after the drug intervention.

Conditions

• Malaria

Interventions

Type	Name	Description
DRUG	Dihydroartemisinin-piperaquine with primaquine	P. falciparum : Treated with fixed doses of 40 mg dihydroartemisinin and 320 mg piperaquine based on weight for 3 days (D0, D1 and D2) with max dose of 1 x 3 tablets for patients weighing ≥ 41 kg; 1 x 2 tablets for patients weighing 31 - 40 kg, 1 x 1.5 tablets for patients weighing 18 - 30 kg, and 1 X 1 tablet for patients with body weight of 11 - 17 kg. A single dose PQ of 0.75 mg/kg BW was provided on Day-3 using 15 mg base PQ tablets. The maximal dose was 3 tablets for subjects weighing ≥ 60 kg. The dose range for subjects weighing 10 - 13 kg was 0.5 tablet; 14 - 18 kg was 0.75 tablet; 19 - 23 kg was 1 tablet, 24 -30 kg was 1.5 tablet; 31 - 40 kg was 2 tablets; 41- 49 kg was 2.25 tablet; 50 - 59 kg was 2.5 tablet and ≥ 60 kg was 3 tablets. P. vivax: DHP (3 days) + primaquine (14 days)

Timeline

• Start date: 2011-02-01
• Primary completion: 2011-11-01
• Completion: 2011-12-01
• First posted: 2011-07-08
• Last updated: 2012-03-23

Locations

1 site across 1 country: Indonesia