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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Inge Sutanto, Indonesia University
ClinicalTrials.gov Identifier:
NCT01389557
First received: July 6, 2011
Last updated: March 22, 2012
Last verified: November 2011
  Purpose

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 Intervention Phase
Malaria
Drug: Dihydroartemisinin-piperaquine with primaquine
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Evaluation of Impact Dihydroartemisinin-piperaquine Plus Primaquine on Malaria Transmission in Lempasing Village, Lampung Province, Southern Sumatra

Resource links provided by NLM:


Further study details as provided by Indonesia University:

Primary Outcome Measures:
  • Presence of malaria (P. falciparum and P. vivax) parasites in blood spot [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 77
Study Start Date: February 2011
Study Completion Date: December 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
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
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01389557

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

No publications provided

Responsible Party: Inge Sutanto, DR Inge Sutanto MPHil, Department of Parasitology, Faculty of Medicine, Indonesia University
ClinicalTrials.gov Identifier: NCT01389557     History of Changes
Other Study ID Numbers: 45114-2, 45114
Study First Received: July 6, 2011
Last Updated: March 22, 2012
Health Authority: Indonesia: National Agency of Drug and Food Control

Keywords provided by Indonesia University:
malaria
DHP
PQ
MST

Additional relevant MeSH terms:
Malaria
Parasitic Diseases
Protozoan Infections
Artemisinins
Dihydroartemisinin
Piperaquine
Primaquine
Anti-Infective Agents
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014