Last Updated: 16/06/2015
Intermittent Screening and Treatment for the control of malaria in the first year of life in Papua, Indonesia: A cluster randomized controlled trial
Objectives
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:
- 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.
- To evaluate the safety, efficacy and population pharmacokinetics of DHP in children under 1 year of age.
In Papua Indonesia P. falciparum and P. vivax exert a considerable burden of disease. Almost a third of hospitalized infants have a patent parasitaemia with infections associated with high rates of severe anaemia and respiratory insufficiency. Clinical malaria is a major contributor to infant mortality rates that exceeds 68/1000 live births.
Following a series of clinical trials, the first line treatment for malaria in Papua including in infants was changed to dihydroartemisinin-piperaquine (DHP) in 2006. However, symptoms of infant malaria are not specific and the diagnosis is often missed and the specific treatment strategy in this age group has not been well defined.
The results of this research can have direct relevance policymakers seeking to reduce the burden of malaria locally, nationally and internationally.
Intervention:
Interventional randomized study. 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.
Primary outcome measured: The incidence of clinical malaria in the first year of life (Total number of new clinical cases per child during the first year of life)
Secondary outcome measured: Proportion of infant with recurrent parasitaemia due to any species at day 42 after treatment with DHP.
The proposed study will enrol 757 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.
ClinicalTrials.gov Identifier: NCT02001428
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 757 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
Jan 2013 — Apr 2017
$383,599
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