Severe and Cerebral Malaria Investigated Through Host Metabolomics

NCT ID: NCT02451904

Last Updated: 2018-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

840 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

* 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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Severe Malaria

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Severe/Cerebral Malaria

Intensive monitoring

Observation

Intervention Type OTHER

Uncomplicated Malaria

Intensive monitoring

Observation

Intervention Type OTHER

Sepsis

Intensive monitoring

Observation

Intervention Type OTHER

Acidosis

Intensive monitoring

Observation

Intervention Type OTHER

Encephalitis

Intensive monitoring

Observation

Intervention Type OTHER

Healthy Individuals

Monitoring

Observation

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Observation

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* Known pre-existing chronic medical conditions including advanced hepatic disease.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chittagong Medical College and Hospital

OTHER

Sponsor Role collaborator

University of Oxford

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Prof. Arjen M. Dondorp, MD

Role: PRINCIPAL_INVESTIGATOR

Mahidol Oxford Tropical Medicine Research Unit

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Chittagong Medical College Hospital (CMCH)

Chittagong, , Bangladesh

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Bangladesh

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 16125588 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21062666 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30566600 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BAKMAL1407

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Role of Nitric Oxide in Malaria
NCT00527163 COMPLETED
DON in Pediatric Cerebral Malaria
NCT05478720 RECRUITING PHASE1/PHASE2