Plasmodium Falciparum MalariaNCT02001428
Malaria in Early Life Study
A study testing dihydroartemisinin-piperaquine in people with Plasmodium Falciparum Malaria and Plasmodium Vivax Malaria, run by Gadjah Mada University at 1 site in Indonesia.
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… Read more about this study
- Who is it for?
- Ages 1 day to 1 year
- Conditions the study is for
- Plasmodium Falciparum Malaria, Plasmodium Vivax Malaria
- What is being tested?
- dihydroartemisinin-piperaquine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 757 participants
- Where
- 1 siteIndonesia
- Study dates
- 21 Jul 2014to 17 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Preterm infants (<37 weeks gestation)
- Sick newborns, requiring hospitalization
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Timika Research Facility
Timika, Special Region of Papua, 99971
About this study
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
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.
Read more
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.
Read the 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.
- Being tested
- dihydroartemisinin-piperaquine
- Keywords
- malaria, vivax, falciparum, infants
- Medical subject headings
- Malaria, Falciparum, Malaria, Vivax, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dihydroartemisinin-piperaquineDrug
Also called DHP
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.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent Screening and Treatment | Experimental | 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. Receives: Drug: dihydroartemisinin-piperaquine |
| Passive Case Detection | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Malaria parasitaemia is assessed by microscopy and PCR.
Measured: Parasitaemia found at day 42 after treatment with DHP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2013 (estimated)
- Study start21 Jul 2014
- Primary completion31 Mar 2016
- Study completion17 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Plasmodium Falciparum MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 757 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gadjah Mada University
- Sponsor type
- University, hospital or other
- Collaborators
- Timika Research Facility, Indonesia, Eijkman Institute for Molecular Biology, Menzies School of Health Research
- Responsible party
- Principal investigator, Dr. Jeanne Rini Poespoprodjo, Gadjah Mada University
- Investigators
- Jeanne R Poespoprodjo, MD, MSc, PhD, Principal investigator, University of Gadjah Madah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02001428
- Sponsor's protocol ID
- WT099875_Malaria in Early Life
- Status last verified
- Jul 2018
- First submitted
- 20 Nov 2013
- Last updated
- 2 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 35672703
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02001428
- Acronym / sponsor ID
- WT099875_Malaria in Early Life
- Keywords
- malaria, vivax, falciparum, infants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 757 participants (actual)
- Lead sponsor
- Gadjah Mada UniversityUniversity, hospital or other
- Collaborators
- Timika Research Facility, Indonesia, Eijkman Institute for Molecular Biology, Menzies School of Health Research
- Study start
- 21 Jul 2014 (actual)
- Primary completion
- 31 Mar 2016 (actual)
- Study completion
- 17 May 2017 (actual)
- First posted
- 4 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent Screening and Treatment | Experimental | Drug: dihydroartemisinin-piperaquineInfants 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 intervention | –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. |
Who may qualify
- Ages
- 1 day to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Preterm infants (<37 weeks gestation)
- Sick newborns, requiring hospitalization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dihydroartemisinin-piperaquineAlso: DHPParticipating 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. | Drug | Intermittent Screening and Treatment |
Primary outcome
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
The total number of new clinical malaria cases from birth to one year old will be measured at one year of age.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2018.
- Derived from this study: PubMed 35672703Poespoprodjo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeanne R Poespoprodjo, MD, MSc, PhD principal investigator
University of Gadjah Madah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dihydroartemisinin-piperaquine in people with Plasmodium Falciparum Malaria and Plasmodium Vivax Malaria, run by Gadjah Mada University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02001428, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2018.