Malaria in Early Life Study
Condition: Plasmodium Falciparum Malaria; Plasmodium Vivax Malaria
MeSH terms: Malaria; Malaria, Falciparum; Malaria, Vivax
Study type: Interventional

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.
    

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.
    

Intervention name(s): dihydroartemisinin-piperaquine
Intervention type(s): Drug
Intervention description(s): 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 intervention name(s): DHP
Intervention MeSH terms: Piperaquine; Artenimol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: malaria; vivax; falciparum; infants