Malaria in Early Life Study
Intermittent Screening and Treatment for the Control of Malaria in the First Year of Life in Papua, Indonesia: A Cluster Randomized Controlled Trial
1 other identifier
interventional
757
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 20, 2013
CompletedFirst Posted
Study publicly available on registry
December 4, 2013
CompletedStudy Start
First participant enrolled
July 21, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 17, 2017
CompletedAugust 2, 2018
July 1, 2018
1.7 years
November 20, 2013
July 31, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Proportion of infant with recurrent parasitaemia due to any species at day 42 after treatment with DHP.
Parasitaemia found at day 42 after treatment with DHP
Other Outcomes (2)
Prevalence of anaemia and malaria at 6 and 12 months of age.
Prevalence will be assessed at 6 and 12 months of age
Population mean pharmacokinetic profile of Piperaquine
the piperaquine level will be assessed at day 0,1,2,7,14,21,28,35 and 42 after treatment with DHP
Study Arms (2)
Intermittent Screening and Treatment
EXPERIMENTALInfants enrolled at Village health posts will be randomly allocated to receive intermittent screening and treatment (IST) on every scheduled immunization visit at 2, 3, 4 and 9 months of age. Infants in this group will be screened for malaria by Rapid Diagnostic Test (RDT), and if positive, treated with dihydroartemisinin-piperaquine (DHP). Infants will also receive follow up home visits at 6 and 12 months.
Passive Case Detection
NO INTERVENTIONInfants in the control arm will only be checked for malaria if they have fever, or history of fever in the 24 hours prior to the scheduled immunization visit at 2,3,4 and 9 months of age, or at a follow up home visit at 6 and 12 months. Infants with malaria will be treated with DHP once daily for 3 days according to local treatment guidelines.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Preterm infants (\<37 weeks gestation)
- Sick newborns, requiring hospitalization
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gadjah Mada Universitylead
- Timika Research Facility, Indonesiacollaborator
- Eijkman Institute for Molecular Biologycollaborator
- Menzies School of Health Researchcollaborator
Study Sites (1)
Timika Research Facility
Timika, Special Region of Papua, 99971, Indonesia
Related Publications (1)
Poespoprodjo JR, Hafiidhaturrahmah, Sariyanti N, Indrawanti R, McLean ARD, Simpson JA, Kenangalem E, Burdam FH, Noviyanti R, Trianty L, Fadhilah C, Soenarto Y, Price RN. Intermittent screening and treatment for malaria complementary to routine immunisation in the first year of life in Papua, Indonesia: a cluster randomised superiority trial. BMC Med. 2022 Jun 8;20(1):190. doi: 10.1186/s12916-022-02394-1.
PMID: 35672703DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeanne R Poespoprodjo, MD, MSc, PhD
University of Gadjah Madah
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Maternal and Child Health Consultant
Study Record Dates
First Submitted
November 20, 2013
First Posted
December 4, 2013
Study Start
July 21, 2014
Primary Completion
March 31, 2016
Study Completion
May 17, 2017
Last Updated
August 2, 2018
Record last verified: 2018-07