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
Verified date | July 2018 |
Source | Gadjah Mada University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Indonesia | Timika Research Facility | Timika | Papua |
Lead Sponsor | Collaborator |
---|---|
Gadjah Mada University | Eijkman Institute, Jakarta, Indonesia, Menzies School of Health Research, Timika Research Facility, Indonesia |
Indonesia,
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 |
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