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NCT02793336: ELIPI
Early Life Cohort in Papua Indonesia (ELIPI Study)
trial in Malaria in 500 participants. Completed in 12 March 2024.
12 March 2024
Quick facts
| Lead sponsor | Menzies School of Health Research |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 500 |
| Start date | 3 August 2016 |
| Primary completion | 12 March 2024 |
| Estimated completion | 12 March 2024 |
| Sites | 1 location across Indonesia |
Conditions studied
- Malaria — all drugs for Malaria →
Sponsor
Menzies School of Health Research
Who can join
Adults 1 to 5, any sex, with Malaria. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02793336
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Malaria
Currently open trials in the same condition.
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- NCT07036159 — A Study to Assess the Safety and Immunogenicity of a Vaccine Against Malaria in Healthy Children Aged 5-60 Months · Phase 2 · recruiting
- NCT06735209 — First-in-Human PfSPZ-LARC2 Vaccination/CHMI · Phase 1 · active not recruiting
- NCT06854042 — A Study of Oral E1018 in Healthy Adult Participants · Phase 1 · recruiting
- NCT06607003 — Induced Blood-Stage Malaria in Healthy Malaria-Naive Adults to Assess the Safety and Infectivity of Plasmodium Vivax Cha · Phase 1 · recruiting
Other Menzies School of Health Research trials
Trials by the same sponsor.
- NCT07468526 — An Ultra-short Course of Primaquine for the Radical Cure of Vivax Malaria · Phase 3 · not yet recruiting
- NCT07468513 — Primaquine for Vivax Malaria in G6PD Intermediate and Deficient Cases. · Phase 4 · recruiting
- NCT06148792 — A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria · Phase 3 · recruiting
- NCT05879224 — Short Course Primaquine for the Radical Cure of P. Vivax Malaria - Indonesia · NA · completed
- NCT05629416 — The Communicate Study Partnership · Phase 2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02793336 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Menzies School of Health Research
- Last refreshed: 15 March 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02793336.
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