NCT02451904

Brief Summary

  • The aim is to describe disease mechanisms of severe and cerebral malaria and identify new targets for adjunctive therapies.
  • 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
840

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 22, 2015

Completed
10 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

June 20, 2018

Status Verified

June 1, 2018

Enrollment Period

2.3 years

First QC Date

May 15, 2015

Last Update Submit

June 19, 2018

Conditions

Severe Malaria

Keywords

PathogenesisMicrovascular functionMetabolic dysregulationMetabolomics

Outcome Measures

Primary Outcomes (1)

  • Characterisation of patterns of metabolic dysregulation in severe malaria

    Interrelationship between disturbances in metabolic pathways associated with acidosis and cerebral malaria

    4-6 weeks

Study Arms (6)

Severe/Cerebral Malaria

Intensive monitoring

Other: Observation

Uncomplicated Malaria

Intensive monitoring

Other: Observation

Sepsis

Intensive monitoring

Other: Observation

Acidosis

Intensive monitoring

Other: Observation

Encephalitis

Intensive monitoring

Other: Observation

Healthy Individuals

Monitoring

Other: Observation

Interventions

ObservationOTHER
AcidosisEncephalitisHealthy IndividualsSepsisSevere/Cerebral MalariaUncomplicated Malaria

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

In total, up to 840 patients may be enrolled in this study.

You may qualify if:

  • Age \> 12 years
  • 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

You may not qualify if:

  • Known pre-existing chronic medical conditions including advanced hepatic disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chittagong Medical College Hospital (CMCH)

Chittagong, Bangladesh

Location

Related Publications (3)

  • 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.

    PMID: 16125588BACKGROUND

  • 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.

    PMID: 21062666BACKGROUND

  • 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.

    PMID: 30566600DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood, Urine, CSF, Stool

MeSH Terms

Conditions

Malaria

Interventions

Observation

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Prof. Arjen M. Dondorp, MD

    Mahidol Oxford Tropical Medicine Research Unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2015

First Posted

May 22, 2015

Study Start

June 1, 2015

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

June 20, 2018

Record last verified: 2018-06

Locations

BA(1)