Recruitment

Recruitment Status
Completed
Estimated Enrollment
756

Inclusion Criterias

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

Exclusion Criterias

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

Summary

Conditions
  • Plasmodium Falciparum Malaria
  • Plasmodium Vivax Malaria
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Younger than 1 years
Gender
Both males and females

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 ...

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.

Inclusion Criterias

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

Exclusion Criterias

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

Locations

Timika, Papua, 99971
Timika, Papua, 99971

Tracking Information

NCT #
NCT02001428
Collaborators
  • Timika Research Facility, Indonesia
  • Eijkman Institute for Molecular Biology
  • Menzies School of Health Research
Investigators
  • Principal Investigator: Jeanne R Poespoprodjo, MD, MSc, PhD University of Gadjah Madah
  • Jeanne R Poespoprodjo, MD, MSc, PhD University of Gadjah Madah