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Malaria in Early Life Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Gadjah Mada University
Sponsor:
Collaborators:
Timika Research Facility, Indonesia
Eijkman Institute, Jakarta, Indonesia
Menzies School of Health Research
Information provided by (Responsible Party):
Dr. Jeanne Rini Poespoprodjo, Gadjah Mada University
ClinicalTrials.gov Identifier:
NCT02001428
First received: November 20, 2013
Last updated: May 31, 2014
Last verified: May 2014
  Purpose

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.

Condition Intervention
Plasmodium Falciparum Malaria
Plasmodium Vivax Malaria
Drug: dihydroartemisinin-piperaquine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Gadjah Mada University:

Primary Outcome Measures:
  • The incidence of clinical malaria in the first year of life [ Time Frame: Total number of new clinical cases per child during the first year of life ] [ Designated as safety issue: No ]
    The total number of new clinical malaria cases from birth to one year old will be measured at one year of age.


Secondary Outcome Measures:
  • Proportion of infant with recurrent parasitaemia due to any species at day 42 after treatment with DHP. [ Time Frame: Parasitaemia found at day 42 after treatment with DHP ] [ Designated as safety issue: No ]
    Malaria parasitaemia is assessed by microscopy and PCR.


Other Outcome Measures:
  • Prevalence of anaemia and malaria at 6 and 12 months of age. [ Time Frame: Prevalence will be assessed at 6 and 12 months of age ] [ Designated as safety issue: No ]
  • Population mean pharmacokinetic profile of Piperaquine [ Time Frame: the piperaquine level will be assessed at day 0,1,2,7,14,21,28,35 and 42 after treatment with DHP ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 756
Study Start Date: May 2014
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intermittent Screening and Treatment
Infants 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.
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.
Other Name: DHP
No Intervention: Passive Case Detection
Infants 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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02001428

Contacts
Contact: Jeanne R Poespoprodjo, MD, Msc, PhD didot2266@yahoo.com

Locations
Indonesia
Timika Research Facility Recruiting
Timika, Papua, Indonesia, 99971
Contact: Jeanne R Poespoprodjo, MD, Ph.D    +62811490738    didot2266@yahoo.com   
Contact: Hafiidhaturrahmah , MD    +6285338648900    avis.indonesia@gmail.com   
Principal Investigator: Jeanne R Poespoprodjo, MD, Msc, PhD         
Sub-Investigator: Enny Kenangalem, MD, MSc, PhD         
Sponsors and Collaborators
Gadjah Mada University
Timika Research Facility, Indonesia
Eijkman Institute, Jakarta, Indonesia
Menzies School of Health Research
Investigators
Principal Investigator: Jeanne R Poespoprodjo, MD, MSc, PhD University of Gadjah Madah
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Jeanne Rini Poespoprodjo, Maternal and Child Health Consultant, Gadjah Mada University
ClinicalTrials.gov Identifier: NCT02001428     History of Changes
Other Study ID Numbers: WT099875_Malaria in Early Life
Study First Received: November 20, 2013
Last Updated: May 31, 2014
Health Authority: Indonesia: Departement Kesehatan (Department of Health)
Australia: Human Research Ethics Committee

Keywords provided by Gadjah Mada University:
malaria
vivax
falciparum
infants

Additional relevant MeSH terms:
Malaria
Malaria, Falciparum
Malaria, Vivax
Protozoan Infections
Parasitic Diseases
Dihydroartemisinin
Artemisinins
Piperaquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014