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

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.

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Key information

Conditions

Malaria Infections Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Inge Sutanto, Hanura Primary Health Center

Lampung, Sumatra, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All individuals residing Lempasing village, kecamatan Hanura, Lampung province during study period

Exclusion criteria

Individuals with severe or chronic disease (liver, kidney), infant and pregnant or breastfeeding woman
Individuals that refuse to sign informed consent are excluded.
normal glucose-6-phosphate dehydrogenase enzyme level based on qualitative test (Trinity Biotech® no 203, USA)
willingness to sign the informed-consent form

Treatment and study plan

Dihydroartemisinin-piperaquine with primaquine

Drug

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)

Other names: DHP, PQ

Primary outcomes

Presence of malaria (P. falciparum and P. vivax) parasites in blood spot

Time frame: 6 months

Finger prick blood samples are collected for malaria blood smear. Thick and thin blood smears were stained with 3% Giemsa solution for 40 minutes and were read under binocular microscope with 1,000X magnification.

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2011
First posted: Jul 8, 2011
Registry last updated: Mar 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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