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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01389557
Recruitment Status : Completed
First Posted : July 8, 2011
Last Update Posted : March 23, 2012
Information provided by (Responsible Party):
Inge Sutanto, 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.

Condition or disease Intervention/treatment Phase
Malaria Drug: Dihydroartemisinin-piperaquine with primaquine Phase 4

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Evaluation of Impact Dihydroartemisinin-piperaquine Plus Primaquine on Malaria Transmission in Lempasing Village, Lampung Province, Southern Sumatra
Study Start Date : February 2011
Actual Primary Completion Date : November 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria
U.S. FDA Resources

Intervention Details:
    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)

    Other Name: DHP, PQ

Primary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01389557

Inge Sutanto, Hanura Primary Health Center
Lampung, Sumatra, Indonesia
Sponsors and Collaborators
Indonesia University
Principal Investigator: Inge Sutanto, Md PhD Univesity of Indonesia

Responsible Party: Inge Sutanto, DR Inge Sutanto MPHil, Department of Parasitology, Faculty of Medicine, Indonesia University Identifier: NCT01389557     History of Changes
Other Study ID Numbers: 45114-2
45114 ( Other Grant/Funding Number: Bill and Melinda Gates Foundation )
First Posted: July 8, 2011    Key Record Dates
Last Update Posted: March 23, 2012
Last Verified: November 2011

Keywords provided by Inge Sutanto, Indonesia University:

Additional relevant MeSH terms:
Protozoan Infections
Parasitic Diseases
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents