Back to resultsDihydroartemisinin-piperaquine and Primaquine for Uncomplicated Plasmodium Falciparum Cases (DHP+PQ)
Primary Purpose
Malaria
Status
Completed
Phase
Phase 4
Locations
Indonesia
Study Type
Interventional
Intervention
dihydroartemisinin-piperaquine
dihydroartemisinin-piperaquine + primaquine
Sponsored by
About this trial
This is an interventional prevention trial for Malaria focused on measuring malaria, DHP, PQ, gametocytes
Eligibility 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.
Sites / Locations
- Hanura Primary Health Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
dihydroartemisinin-piperaquine
Dihydroartemisininpiperaquine primaquine
Arm Description
Outcomes
Primary Outcome Measures
Development of sexual stages of P.falciparum
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01392014
Brief Title
Dihydroartemisinin-piperaquine and Primaquine for Uncomplicated Plasmodium Falciparum Cases
Acronym
DHP+PQ
Official Title
Effectiveness of Dihydroartemisinin-piperaquine With or Without Primaquine on Gametocytes Plasmodium Falciparum in Mesoendemic Area of Indonesia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Indonesia University
4. Oversight
Data Monitoring Committee
No
5. 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.
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:
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
Keywords
malaria, DHP, PQ, gametocytes
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
374 (Actual)
8. Arms, Groups, and Interventions
Arm Title
dihydroartemisinin-piperaquine
Arm Type
Active Comparator
Arm Title
Dihydroartemisininpiperaquine primaquine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
dihydroartemisinin-piperaquine
Other Intervention Name(s)
DHP
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
dihydroartemisinin-piperaquine + primaquine
Other Intervention Name(s)
DHP, PQ
Intervention Description
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.
Primary Outcome Measure Information:
Title
Development of sexual stages of P.falciparum
Description
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.
Time Frame
42 days post treatment
Secondary Outcome Measure Information:
Title
Clearance of asexual stages P.falciparum
Description
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.
Time Frame
42 days post treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Inge Sutanto, MD
Organizational Affiliation
Univesity of Indonesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hanura Primary Health Center
City
Lampung
State/Province
Sumatra
Country
Indonesia
12. IPD Sharing Statement
Citations:
PubMed Identifier
23175563
Citation
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.
Results Reference
derived
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Dihydroartemisinin-piperaquine and Primaquine for Uncomplicated Plasmodium Falciparum Cases
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