Malaria in Early Life Study

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02001428
• Other study ID #: WT099875_Malaria in Early Life
• Status: Completed
• Phase: N/A
• Start date: July 21, 2014
• Est. completion date: May 17, 2017

Study information

• Verified date: July 2018
• Source: Gadjah Mada University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 757
• Est. completion date: May 17, 2017
• Est. primary completion date: March 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Year

Eligibility

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

Related Conditions & MeSH terms

• Malaria
• Malaria, Falciparum
• Malaria, Vivax
• Plasmodium Falciparum Malaria
• Plasmodium Vivax Malaria

Intervention

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.

Locations

Country	Name	City	State
Indonesia	Timika Research Facility	Timika	Papua

Sponsors (4)

Lead Sponsor	Collaborator
Gadjah Mada University	Eijkman Institute, Jakarta, Indonesia, Menzies School of Health Research, Timika Research Facility, Indonesia

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Prevalence of anaemia and malaria at 6 and 12 months of age.		Prevalence will be assessed at 6 and 12 months of age
Other	Population mean pharmacokinetic profile of Piperaquine	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
Primary	The incidence of clinical malaria in 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	Proportion of infant with recurrent parasitaemia due to any species at day 42 after treatment with DHP.	Malaria parasitaemia is assessed by microscopy and PCR.	Parasitaemia found at day 42 after treatment with DHP