Impact of Dihydroartemisinin-piperaquine Plus Primaquine on Malaria Transmission in Lampung Province, Sumatra
Primary Purpose
Malaria
Status
Completed
Phase
Phase 4
Locations
Indonesia
Study Type
Interventional
Intervention
Dihydroartemisinin-piperaquine with primaquine
Sponsored by
About this trial
This is an interventional treatment trial for Malaria focused on measuring malaria, DHP, PQ, MST
Eligibility 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
Sites / Locations
- Inge Sutanto, Hanura Primary Health Center
Outcomes
Primary Outcome Measures
Presence of malaria (P. falciparum and P. vivax) parasites in blood spot
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01389557
Brief Title
Impact of Dihydroartemisinin-piperaquine Plus Primaquine on Malaria Transmission in Lampung Province, Sumatra
Official Title
Evaluation of Impact Dihydroartemisinin-piperaquine Plus Primaquine on Malaria Transmission in Lempasing Village, Lampung Province, Southern Sumatra
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
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 PQ on malaria transmission on a community wide level in Lempasing, Lampung, Sumatra.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
Keywords
malaria, DHP, PQ, MST
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Dihydroartemisinin-piperaquine with primaquine
Other Intervention Name(s)
DHP, PQ
Intervention Description
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)
Primary Outcome Measure Information:
Title
Presence of malaria (P. falciparum and P. vivax) parasites in blood spot
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
6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Inge Sutanto, Md PhD
Organizational Affiliation
Univesity of Indonesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inge Sutanto, Hanura Primary Health Center
City
Lampung
State/Province
Sumatra
Country
Indonesia
12. IPD Sharing Statement
Learn more about this trial
Impact of Dihydroartemisinin-piperaquine Plus Primaquine on Malaria Transmission in Lampung Province, Sumatra
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