Plasmodium Falciparum Malaria Clinical Trial
Official title:
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.
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.
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