search
Back to results

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
Indonesia University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malaria focused on measuring malaria, DHP, PQ, MST

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
July 6, 2011
Last Updated
March 22, 2012
Sponsor
Indonesia University
search

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

We'll reach out to this number within 24 hrs