Malaria in Early Life Study

July 31, 2018 updated by: Dr. Jeanne Rini Poespoprodjo, Gadjah Mada University

Intermittent Screening and Treatment for the Control of Malaria in the First Year of Life in Papua, Indonesia: A Cluster Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Infant malaria is a major public health issue in Timika, Papua (Indonesia) and the risk starts at birth with the majority of malaria, mostly asymptomatic, in the first 3 days of life. Malaria infection is associated with severe complications, such as severe anaemia and respiratory distress, and can be fatal.

The emergence of multidrug resistant malaria poses a significant health risk to this vulnerable group. In addition, due to non-specific symptoms of malaria found in this age group, the diagnosis is often missed. Early detection and prompt treatment with an effective antimalarial drug is the key to prevent adverse outcomes from malaria in the first year of life.

The first line treatment for uncomplicated malaria in Indonesia is Dihydroartemisinin-piperaquine (DHP), an ACT that has been shown to be highly efficacious in this region, although experience of its use in infants less than one year old is limited.

Although the World Health Organization recommends antimalarial drug efficacy trials in infants, most ACT efficacy studies include children aged one year or older. Drug population pharmacokinetic studies have enrolled younger infants aged 5-6 months old, whereas Intermittent Preventive Treatment in Infants (IPTi) studies usually start with infants as young as 3 months old.

In view of the challenges to identifying an effective malaria treatment for infants in Indonesia, the proposed study has been designed to evaluate the effectiveness of delivering early detection and prompt treatment with DHP at 2, 3, 4 and 9 months of age, linked to local immunization programmes delivered at village health posts (Posyandu), in an area with high drug resistance levels to both P. falciparum and P. vivax. The effectiveness of this approach will be compared to the current practice of passive case detection. We will also define the efficacy and pharmacokinetic profile of DHP in infancy and monitor the safety and toxicity of its use.

The proposed study will enrol 756 infants across 5 health centres in Papua, Indonesia. Infants will be recruited from pregnant mothers who are enrolled as participants of the concurrent STOPMiP trial - a clinical research study which aims to evaluate intermittent screening and treatment (IST) or intermittent preventive therapy (IPT) with DHP in pregnant women in Indonesia.

The trial result will inform policy makers in Indonesia, and internationally, on the effectiveness of different malaria control strategies in the first year of life.

Study Type

Interventional

Enrollment (Actual)

757

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • Papua
      • Timika, Papua, Indonesia, 99971
        • Timika Research Facility

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 year (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Mother of participant is enrolled in the STOP MiP trial
  • Healthy full term newborn of consenting parent
  • Residence in the study area for the duration of the follow up period

Exclusion Criteria:

  • Preterm infants (<37 weeks gestation)
  • Sick newborns, requiring hospitalization

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intermittent Screening and Treatment
Infants enrolled at Village health posts will be randomly allocated to receive intermittent screening and treatment (IST) on every scheduled immunization visit at 2, 3, 4 and 9 months of age. Infants in this group will be screened for malaria by Rapid Diagnostic Test (RDT), and if positive, treated with dihydroartemisinin-piperaquine (DHP). Infants will also receive follow up home visits at 6 and 12 months.
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.
Other Names:
  • DHP
NO_INTERVENTION: Passive Case Detection
Infants in the control arm will only be checked for malaria if they have fever, or history of fever in the 24 hours prior to the scheduled immunization visit at 2,3,4 and 9 months of age, or at a follow up home visit at 6 and 12 months. Infants with malaria will be treated with DHP once daily for 3 days according to local treatment guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of clinical malaria in the first year of life
Time Frame: Total number of new clinical cases per child during the first year of life
The total number of new clinical malaria cases from birth to one year old will be measured at one year of age.
Total number of new clinical cases per child during the first year of life

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of infant with recurrent parasitaemia due to any species at day 42 after treatment with DHP.
Time Frame: Parasitaemia found at day 42 after treatment with DHP
Malaria parasitaemia is assessed by microscopy and PCR.
Parasitaemia found at day 42 after treatment with DHP

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of anaemia and malaria at 6 and 12 months of age.
Time Frame: Prevalence will be assessed at 6 and 12 months of age
Prevalence will be assessed at 6 and 12 months of age
Population mean pharmacokinetic profile of Piperaquine
Time Frame: the piperaquine level will be assessed at day 0,1,2,7,14,21,28,35 and 42 after treatment with DHP
Key pharmacokinetic parameters, CL/F (clearance relative to bioavailability), Vss/F (Volume of distribution at steady state relative to bioavailability), t½,z (elimination half life) will be analysed.
the piperaquine level will be assessed at day 0,1,2,7,14,21,28,35 and 42 after treatment with DHP

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gadjah Mada University

Collaborators

Menzies School of Health Research
Eijkman Institute for Molecular Biology
Timika Research Facility, Indonesia

Investigators

  • Principal Investigator: Jeanne R Poespoprodjo, MD, MSc, PhD, University of Gadjah Madah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 21, 2014

Primary Completion (ACTUAL)

March 31, 2016

Study Completion (ACTUAL)

May 17, 2017

Study Registration Dates

First Submitted

November 20, 2013

First Submitted That Met QC Criteria

November 27, 2013

First Posted (ESTIMATE)

December 4, 2013

Study Record Updates

Last Update Posted (ACTUAL)

August 2, 2018

Last Update Submitted That Met QC Criteria

July 31, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WT099875_Malaria in Early Life

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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