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

Phase 4

Completed

• Conditions: Malaria

• Registration Number: NCT01389557
• Lead Sponsor: Indonesia University

Brief 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.

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-07-06
• Study First Submitted QC: 2011-07-07
• Study First Posted: 2011-07-08
• Status Verified: 2011-11
• Primary Completion: 2011-11
• Study Completion: 2011-12
• Last Update Submitted: 2012-03-22
• Last Update Posted: 2012-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Trial Locations

Locations (1)

Inge Sutanto, Hanura Primary Health Center; 🇮🇩 Lampung, Sumatra, Indonesia