MalariaELIPINCT02793336
Early Life Cohort in Papua Indonesia (ELIPI Study)
An observational study of Malaria, run by Menzies School of Health Research at 1 site in Indonesia.
Trial summary
Malaria remains an important cause of illness in young infants. Our clinical and epidemiological studies in Papua (Indonesia) have shown the magnitude of malaria morbidity in infants in the first 5 years of life, including recurrent episodes of malaria, anaemia, malnutrition and coinfection. Read more about this study
- Who is it for?
- Ages 1 year to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- How many people
- 500 participants
- Where
- 1 siteIndonesia
- Study dates
- 3 Aug 2016to 12 Mar 2024
- Phase
- Observational
- 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 year to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study is designed as a continuation of a cohort of infants from 12 to 48 months of age. This follows on from two previous cohorts: "STOP MIP", which is a cohort of pregnant women followed up until delivery and the "Baby-Cohort study", which enrols babies from mothers in the "STOP MIP" trial and follows them until their first year of live. When participants of the "Baby-cohort Study" reach study end, they are offered to participate in this study.
Who may be able to join
- Patient enrolled in the Baby-Cohort study
Who cannot join
- Patients not enrolled in the Baby-Cohort study
Trial locations and contacts
1 site in 1 country.
About this study
Malaria remains an important cause of illness in young infants. Our clinical and epidemiological studies in Papua (Indonesia) have shown the magnitude of malaria morbidity in infants in the first 5 years of life, including recurrent episodes of malaria, anaemia, malnutrition and coinfection. Together these contribute significantly morbidity in early life, and almost certainly to the very high infant mortality rates in this region. However the body of knowledge around infant malaria outside of Africa, where both species P. vivax and P. falciparum are prevalent is considerable smaller. The impact of recurrent vivax malaria and severe anaemia on neurodevelopment and growth in young children is unknown in Papua.
This study therefore aims to provide longitudinal data on the incidence of symptomatic and asymptomatic malaria (P. falciparum and P. vivax) and the associated risk of anaemia. It also provides an opportunity to assess incidence risk of non-malaria febrile illnesses and bacterial co-infections and the long term outcomes in terms of neurodevelopment and growth in a vulnerable age group. The study is a continuation from two already established cohort studies: "STOP MIP", which enrolled pregnant women and followed them until delivery and a "baby-cohort", which enrolled babies from mothers included in the cohort and followed them through their first year of life. Continuous follow up of those babies until they are 4 years old will increase our understanding of long term impact especially of vivax malaria. The cohort will be linked to a randomized controlled trial (RCT) and will offer cohort patients to be enrolled into the RCT when they are diagnosed with malaria (symptomatic), allowing to estimate treatment effectiveness.
- Conditions
- Malaria
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| infant cohort | The study is designed as a continuation of a cohort of infants from 12 to 48 months of age. This follows on from two previous cohorts: "STOP MIP", which is a cohort of pregnant women followed up until delivery and the "Baby-Cohort study", which enrols babies from mothers in the "STOP MIP" trial and follows them until their first year of live. When participants of the "Baby-cohort Study" reach study end, they are offered to participate in this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
P. vivax parasitaemia (PCR or microscopy)
The incidence rate of any P. vivax parasitaemia (PCR or microscopy) over 1 year in all infants
Measured: 1 year
Secondary outcomes (8)
symptomatic P. vivax
The incidence rate of symptomatic P. vivax over 1 year in all participants
Measured: 1 year
severe anaemia (Hb<7g/dl) and/or blood transfusion
The incidence risk of severe anaemia (Hb<7g/dl) and/or the risk for blood transfusion
Measured: 4 years
serious illnesses including hospitalization
The incidence risk and rate of serious illnesses including hospitalization
Measured: 4 years
non-malarial febrile episodes and bacterial co-infections
The incidence risk and rate of non-malarial febrile episodes and bacterial co-infections
Measured: 4 years
mortality
The incidence risk of mortality
Measured: 4 years
growth retardation and neurodevelopment delay
The incidence risk of growth retardation and neurodevelopment delay
Measured: 4 years
G6PD activity
The distribution of G6PD activity within the study population
Measured: 1 year
Fluorescence spot test results (FST)
The change in FST result performed during the baby cohort study compared to the FST result performed at 12 months age
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study start3 Aug 2016
- Primary completion12 Mar 2024
- Study completion12 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menzies School of Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- Timika Research Facility Kompleks RSMM, Timika-Papua, Indonesia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02793336
- Sponsor's protocol ID
- ELIPI
- Acronym
- ELIPI
- Status last verified
- Mar 2024
- First submitted
- 26 May 2016
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Life Cohort in Papua Indonesia (ELIPI Study)
- ClinicalTrials.gov ID
- NCT02793336
- Acronym / sponsor ID
- ELIPI / ELIPI
- Conditions
- Malaria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Menzies School of Health ResearchUniversity, hospital or other
- Collaborators
- Timika Research Facility Kompleks RSMM, Timika-Papua, Indonesia
- Study start
- 3 Aug 2016 (actual)
- Primary completion
- 12 Mar 2024 (actual)
- Study completion
- 12 Mar 2024 (actual)
- First posted
- 8 Jun 2016 (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.
Malaria remains an important cause of illness in young infants. Our clinical and epidemiological studies in Papua (Indonesia) have shown the magnitude of malaria morbidity in infants in the first 5 years of life, including recurrent episodes of malaria, anaemia, malnutrition and coinfection. Together these contribute significantly morbidity in early life, and almost certainly to the very high infant mortality rates in this region. However the body of knowledge around infant malaria outside of Africa, where both species P. vivax and P. falciparum are prevalent is considerable smaller. The impact of recurrent vivax malaria and severe anaemia on neurodevelopment and growth in young children is unknown in Papua.
This study therefore aims to provide longitudinal data on the incidence of symptomatic and asymptomatic malaria (P. falciparum and P. vivax) and the associated risk of anaemia. It also provides an opportunity to assess incidence risk of non-malaria febrile illnesses and bacterial co-infections and the long term outcomes in terms of neurodevelopment and growth in a vulnerable age group. The study is a continuation from two already established cohort studies: "STOP MIP", which enrolled pregnant women and followed them until delivery and a "baby-cohort", which enrolled babies from mothers included in the cohort and followed them through their first year of life. Continuous follow up of those babies until they are 4 years old will increase our understanding of long term impact especially of vivax malaria. The cohort will be linked to a randomized controlled trial (RCT) and will offer cohort patients to be enrolled into the RCT when they are diagnosed with malaria (symptomatic), allowing to estimate treatment effectiveness.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| infant cohort | – | –The study is designed as a continuation of a cohort of infants from 12 to 48 months of age. This follows on from two previous cohorts: "STOP MIP", which is a cohort of pregnant women followed up until delivery and the "Baby-Cohort study", which enrols babies from mothers in the "STOP MIP" trial and follows them until their first year of live. When participants of the "Baby-cohort Study" reach study end, they are offered to participate in this study. |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study is designed as a continuation of a cohort of infants from 12 to 48 months of age. This follows on from two previous cohorts: "STOP MIP", which is a cohort of pregnant women followed up until delivery and the "Baby-Cohort study", which enrols babies from mothers in the "STOP MIP" trial and follows them until their first year of live. When participants of the "Baby-cohort Study" reach study end, they are offered to participate in this study.
Key inclusion criteria (1 listed)
- Patient enrolled in the Baby-Cohort study
Key exclusion criteria (1 listed)
- Patients not enrolled in the Baby-Cohort study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
P. vivax parasitaemia (PCR or microscopy)
Time frame: 1 year
The incidence rate of any P. vivax parasitaemia (PCR or microscopy) over 1 year in all infants
8 secondary outcomes
symptomatic P. vivax
Time frame: 1 year
severe anaemia (Hb<7g/dl) and/or blood transfusion
Time frame: 4 years
serious illnesses including hospitalization
Time frame: 4 years
non-malarial febrile episodes and bacterial co-infections
Time frame: 4 years
mortality
Time frame: 4 years
growth retardation and neurodevelopment delay
Time frame: 4 years
G6PD activity
Time frame: 1 year
Fluorescence spot test results (FST)
Time frame: 1 year
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 15 Mar 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malaria, run by Menzies School of Health Research 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 1 inclusion and 1 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 15 Mar 2024. 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?
P. vivax parasitaemia (PCR or microscopy) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Mar 2024.