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Dihydroartemisinin-piperaquine and Primaquine for Uncomplicated Plasmodium Falciparum Cases (DHP+PQ)

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ClinicalTrials.gov Identifier: NCT01392014
Recruitment Status : Completed
First Posted : July 12, 2011
Last Update Posted : July 12, 2011
Information provided by:

Study Description
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 or without PQ on the sexual and asexual stages of P. falciparum in Sumatra, Indonesia.

Condition or disease Intervention/treatment Phase
Malaria Drug: dihydroartemisinin-piperaquine Drug: dihydroartemisinin-piperaquine + primaquine Phase 4

Detailed Description:

The study was conducted in Hanura Primary Health Center, Padang Cermin district, Lampung province (105°45'-103°48'E and 3°45'-6°45'S) located at the southern end of Sumatra island.

The study subjects received either 3 day doses of dihydroartemisinin-piperaquine with or without 1 day of primaquine according to their body weight.

Patients with fever or history of fever within the past 24 hours were screened by microscopic examination of Giemsa-stained thick blood films to detect P. falciparum infection.

All subjects were allocated by open-label randomization to receive DHP alone (on Day 0 to Day 2) or DHP plus a single dose of PQ (Day 3). The procedures of drug administration in the study were as follows:

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 374 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effectiveness of Dihydroartemisinin-piperaquine With or Without Primaquine on Gametocytes Plasmodium Falciparum in Mesoendemic Area of Indonesia
Study Start Date : December 2008
Primary Completion Date : March 2010
Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: dihydroartemisinin-piperaquine Drug: dihydroartemisinin-piperaquine
This study used fixed-dose tablets of 40 mg dihydroartemisinin and 320 mg piperaquine for each tablet (D-ARTEPP®, Guilin Pharmaceutical Co., Ltd, China. The regimen is based on weight for 3 days (D0, D1 and D2) with maximal 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.
Other Name: DHP
Active Comparator: Dihydroartemisininpiperaquine primaquine Drug: dihydroartemisinin-piperaquine + primaquine
For DHP, treatment was as for Arm dihydroartemisinin piperaquine. A single dose PQ of 0.75 mg/kg BW was provided on Day-3 using 15 mg base PQ tablets (local product by PT Pharos Indonesia, batch no 15306002, produced on 30/05/2008 and expiring on May 2012). 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.
Other Name: DHP, PQ

Outcome Measures

Primary Outcome Measures :
  1. Development of sexual stages of P.falciparum [ Time Frame: 42 days post treatment ]
    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.

Secondary Outcome Measures :
  1. Clearance of asexual stages P.falciparum [ Time Frame: 42 days post treatment ]
    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.

Eligibility Criteria

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Ages Eligible for Study:   4 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • age ≥ 4 years old
  • parasite count ≥ 1,000 asexual parasites/µL
  • normal glucose-6-phosphate dehydrogenase enzyme level based on qualitative test (Trinity Biotech® no 203, USA)
  • hemoglobin level ≥ 8 gr/dL as measured by Hemoque® apparatus;
  • have the ability to return for 42-day-follow up and
  • willingness to sign the informed-consent form.

Exclusion Criteria:

  • are infected with other r plasmodium species
  • have only gametocytes of P. falciparum;
  • are pregnant - measured by positive result on HCG urine test and/or breastfeeding women
  • present signs of pitting edema on both legs as a sign of malnutrition
  • have complicated or severe malaria, other chronic diseases or history of drug allergies.
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01392014

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Inge Sutanto, Parasitologi Fakultas Kedokteran, University of Indonesia
ClinicalTrials.gov Identifier: NCT01392014     History of Changes
Other Study ID Numbers: 45114
45114 ( Other Grant/Funding Number: Bill and Melinda Gates Foundation )
First Posted: July 12, 2011    Key Record Dates
Last Update Posted: July 12, 2011
Last Verified: August 2008

Keywords provided by Indonesia University:

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