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

This study has been completed.
Sponsor:
Information provided by:
Indonesia University
ClinicalTrials.gov Identifier:
NCT01392014
First received: June 24, 2011
Last updated: July 8, 2011
Last verified: August 2008

June 24, 2011
July 8, 2011
December 2008
March 2010   (final data collection date for primary outcome measure)
Development of sexual stages of P.falciparum [ Time Frame: 42 days post treatment ] [ 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.
Same as current
Complete list of historical versions of study NCT01392014 on ClinicalTrials.gov Archive Site
Clearance of asexual stages P.falciparum [ Time Frame: 42 days post treatment ] [ 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.
Same as current
Not Provided
Not Provided
 
Dihydroartemisinin-piperaquine and Primaquine for Uncomplicated Plasmodium Falciparum Cases
Effectiveness of Dihydroartemisinin-piperaquine With or Without Primaquine on Gametocytes Plasmodium Falciparum in Mesoendemic Area of Indonesia

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.

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:

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Malaria
  • 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
  • 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
  • Active Comparator: dihydroartemisinin-piperaquine
    Intervention: Drug: dihydroartemisinin-piperaquine
  • Active Comparator: Dihydroartemisininpiperaquine primaquine
    Intervention: Drug: dihydroartemisinin-piperaquine + primaquine
Sutanto I, Suprijanto S, Kosasih A, Dahlan MS, Syafruddin D, Kusriastuti R, Hawley WA, Lobo NF, Ter Kuile FO. The effect of primaquine on gametocyte development and clearance in the treatment of uncomplicated falciparum malaria with dihydroartemisinin-piperaquine in South sumatra, Western indonesia: an open-label, randomized, controlled trial. Clin Infect Dis. 2013 Mar;56(5):685-93. doi: 10.1093/cid/cis959. Epub 2012 Nov 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
374
October 2010
March 2010   (final data collection date for primary outcome measure)

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.
Both
4 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Indonesia
 
NCT01392014
45114, 45114
No
Dr. Inge Sutanto, Parasitologi Fakultas Kedokteran, University of Indonesia
Indonesia University
Not Provided
Principal Investigator: Inge Sutanto, MD Univesity of Indonesia
Indonesia University
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP