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Malaria in Early Life Study

NCT02001428 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 757

Last updated 2018-08-02

No results posted yet for this study

Summary

The purpose of this study is to assess the effectiveness of different malaria control strategies in the first year of life.

The effectiveness of delivering an intermittent screening and treatment programme with dihydroartemisinin-piperaquine (DHP), linked to local immunization programmes, will be compared to the current practice of passive case detection of malaria.

This study has two objectives:

1. To assess the effectiveness of intermittent screening and treatment with dihydroartemisinin-piperaquine (DHP) administered at 2, 3, 4 and 9 months of age compared with the current practice of passive detection and treatment for malaria in an area with high drug resistance levels to both P. falciparum and P. vivax.
2. To evaluate the safety, efficacy and population pharmacokinetics of DHP in children under 1 year of age.

Conditions

  • Plasmodium Falciparum Malaria
  • Plasmodium Vivax Malaria

Interventions

DRUG

dihydroartemisinin-piperaquine

Participating infants with uncomplicated malaria will be treated with a three day course (1 dose/day) of DHP (containing 40 mg dihydroartemisinin and 320 mg piperaquine) administered as a total dose over three days of 6mg/kg of dihydroartemisinin and 57 mg/kg of piperaquine.

Sponsors & Collaborators

  • Timika Research Facility, Indonesia

    collaborator UNKNOWN

  • Eijkman Institute for Molecular Biology

    collaborator OTHER

  • Menzies School of Health Research

    collaborator OTHER

  • Gadjah Mada University

    lead OTHER

Principal Investigators

  • Jeanne R Poespoprodjo, MD, MSc, PhD · University of Gadjah Madah

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-21
Primary Completion
2016-03-31
Completion
2017-05-17

Countries

  • Indonesia

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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 NCT02001428 on ClinicalTrials.gov