Severe and Cerebral Malaria Investigated Through Host Metabolomics
NCT ID: NCT02451904
Last Updated: 2018-06-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
840 participants
OBSERVATIONAL
2015-06-30
2017-09-30
Brief Summary
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* Despite treatment between 10-30% of patients with severe malaria die.
* Metabolic acidosis and cerebral malaria are major complications associated with mortality across all age groups. Still, their underlying pathogenesis remains incompletely understood.
* Using a metabolomics approach, this study aims to characterise the spectrum of acids accumulating during acidosis, and investigate patterns of metabolic dysregulation associated with coma and seizures.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Severe/Cerebral Malaria
Intensive monitoring
Observation
Uncomplicated Malaria
Intensive monitoring
Observation
Sepsis
Intensive monitoring
Observation
Acidosis
Intensive monitoring
Observation
Encephalitis
Intensive monitoring
Observation
Healthy Individuals
Monitoring
Observation
Interventions
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Observation
Eligibility Criteria
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Inclusion Criteria
* Full informed written consent obtained
Encephalitis:
* GCS \< 11/15
* Documented fever \> 38°C
* Onset of symptoms \< 2 weeks, with an indication a lumbar puncture as part of the diagnostic work up
* Negative peripheral blood slide for any stages of malaria parasites or a negative rapid diagnostic test for falciparum and vivax malaria
* Age \> 12 years
* Full informed written consent obtained
Healthy volunteers:
* No chronic or acute disease
* No fever in the past 2 weeks
* Age \> 16 years
* Full informed written consent obtained
Exclusion Criteria
12 Years
ALL
Yes
Sponsors
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Chittagong Medical College and Hospital
OTHER
University of Oxford
OTHER
Responsible Party
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Principal Investigators
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Prof. Arjen M. Dondorp, MD
Role: PRINCIPAL_INVESTIGATOR
Mahidol Oxford Tropical Medicine Research Unit
Locations
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Chittagong Medical College Hospital (CMCH)
Chittagong, , Bangladesh
Countries
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References
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Dondorp A, Nosten F, Stepniewska K, Day N, White N; South East Asian Quinine Artesunate Malaria Trial (SEAQUAMAT) group. Artesunate versus quinine for treatment of severe falciparum malaria: a randomised trial. Lancet. 2005 Aug 27-Sep 2;366(9487):717-25. doi: 10.1016/S0140-6736(05)67176-0.
Dondorp AM, Fanello CI, Hendriksen IC, Gomes E, Seni A, Chhaganlal KD, Bojang K, Olaosebikan R, Anunobi N, Maitland K, Kivaya E, Agbenyega T, Nguah SB, Evans J, Gesase S, Kahabuka C, Mtove G, Nadjm B, Deen J, Mwanga-Amumpaire J, Nansumba M, Karema C, Umulisa N, Uwimana A, Mokuolu OA, Adedoyin OT, Johnson WB, Tshefu AK, Onyamboko MA, Sakulthaew T, Ngum WP, Silamut K, Stepniewska K, Woodrow CJ, Bethell D, Wills B, Oneko M, Peto TE, von Seidlein L, Day NP, White NJ; AQUAMAT group. Artesunate versus quinine in the treatment of severe falciparum malaria in African children (AQUAMAT): an open-label, randomised trial. Lancet. 2010 Nov 13;376(9753):1647-57. doi: 10.1016/S0140-6736(10)61924-1. Epub 2010 Nov 7.
Leopold SJ, Ghose A, Allman EL, Kingston HWF, Hossain A, Dutta AK, Plewes K, Chotivanich K, Day NPJ, Tarning J, Winterberg M, White NJ, Llinas M, Dondorp AM. Identifying the Components of Acidosis in Patients With Severe Plasmodium falciparum Malaria Using Metabolomics. J Infect Dis. 2019 May 5;219(11):1766-1776. doi: 10.1093/infdis/jiy727.
Other Identifiers
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BAKMAL1407
Identifier Type: -
Identifier Source: org_study_id
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