Early Life Cohort in Papua Indonesia (ELIPI Study)

Malaria Clinical Trial

— ELIPI  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02793336
• Other study ID #: ELIPI
• Status: Completed
• Start date: August 3, 2016
• Est. completion date: March 12, 2024

Study information

• Verified date: March 2024
• Source: Menzies School of Health Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: March 12, 2024
• Est. primary completion date: March 12, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 5 Years

Eligibility

Inclusion Criteria:

• Patient enrolled in the Baby-Cohort study

Exclusion Criteria:

• Patients not enrolled in the Baby-Cohort study

Related Conditions & MeSH terms

• Malaria

Locations

Country	Name	City	State
Indonesia	Timika Research Facility	Timika	Timika-Papua

Sponsors (2)

Lead Sponsor	Collaborator
Menzies School of Health Research	Timika Research Facility Kompleks RSMM, Timika-Papua, Indonesia

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	P. vivax parasitaemia (PCR or microscopy)	The incidence rate of any P. vivax parasitaemia (PCR or microscopy) over 1 year in all infants	1 year
Secondary	symptomatic P. vivax	The incidence rate of symptomatic P. vivax over 1 year in all participants	1 year
Secondary	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	4 years
Secondary	serious illnesses including hospitalization	The incidence risk and rate of serious illnesses including hospitalization	4 years
Secondary	non-malarial febrile episodes and bacterial co-infections	The incidence risk and rate of non-malarial febrile episodes and bacterial co-infections	4 years
Secondary	mortality	The incidence risk of mortality	4 years
Secondary	growth retardation and neurodevelopment delay	The incidence risk of growth retardation and neurodevelopment delay	4 years
Secondary	G6PD activity	The distribution of G6PD activity within the study population	1 year
Secondary	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	1 year