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


Condition Intervention Phase
Malaria
Drug: dihydroartemisinin-piperaquine
Drug: dihydroartemisinin-piperaquine + primaquine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effectiveness of Dihydroartemisinin-piperaquine With or Without Primaquine on Gametocytes Plasmodium Falciparum in Mesoendemic Area of Indonesia

Resource links provided by NLM:


Further study details as provided by Indonesia University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 374
Study Start Date: December 2008
Study Completion Date: October 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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:

  Eligibility

Ages Eligible for Study:   4 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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: NCT01392014

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

No publications provided by Indonesia University

Additional 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
Study First Received: June 24, 2011
Last Updated: July 8, 2011
Health Authority: Indonesia: National Agency of Drug and Food Control

Keywords provided by Indonesia University:
malaria
DHP
PQ
gametocytes

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

ClinicalTrials.gov processed this record on July 29, 2014