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Impact of Dihydroartemisinin-piperaquine Plus Primaquine on Malaria Transmission in Lampung Province, Sumatra

NCT01389557 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2012-03-23

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Dihydroartemisinin-piperaquine with primaquine

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)

Sponsors & Collaborators

  • Indonesia University

    lead OTHER

Principal Investigators

  • Inge Sutanto, Md PhD · Univesity of Indonesia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2011-11-30
Completion
2011-12-31

Countries

  • Indonesia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01389557 on ClinicalTrials.gov