Severe and Cerebral Malaria Investigated Through Host Metabolomics

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University of Oxford

Status

Completed

Conditions

Severe Malaria

Treatments

Other: Observation

Study type

Observational

Funder types

Other

Identifiers

NCT02451904
BAKMAL1407

Details and patient eligibility

About

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.

Enrollment

840 patients

Sex

All

Ages

12+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Severe/Cerebral Malaria:

  • Any P. falciparum parasitaemia detected by asexual stages on a peripheral blood-slide or a positive rapid diagnostic test in combination with one or more Modified WHO Criteria for Severe Malaria (Hien et al, 1996)
  • < 24 hours after treatment commencement with either parenteral artemisinin or quinine
  • Age > 12 years
  • Full informed written consent obtained

Uncomplicated malaria:

  • Any level of Plasmodium parasitaemia, detected by asexual stages on a peripheral blood-slide or a positive rapid diagnostic test without any of the complications of severe malaria stated above.
  • Age > 12 years
  • Full informed written consent obtained

Sepsis:

Clinical signs of infection in combination with any two of the following signs:

  • Heart rate > 90 beats per minute;
  • Respiratory rate > 20 breaths per minute, a PaCO2 of < 32 mmHg, or the use of mechanical ventilation for an acute respiratory process;
  • Tympanic temperature > 38°C or < 36 °C;
  • White-cell count of > 12x109/L or < 4x109/L, or a differential count showing 10% immature neutrophils ;
  • Negative peripheral blood slide for any stages of malaria parasites or a negative rapid diagnostic test for falciparum and vivax malaria
  • [As bacterial culture is not routinely available at the study site, positivity of cultures is not required]
  • Age > 12 years
  • Full informed written consent obtained

Acidosis:

Clinical suspicion of metabolic acidosis in combination with any of the following:

  • Peripheral venous bicarbonate < 15 mmol/L
  • Peripheral venous base excess < -3 mmol/L
  • Negative peripheral blood slide for any stages of malaria parasites or a negative rapid diagnostic test for falciparum and vivax malaria; and not meeting any of the inclusion criteria for sepsis as stated above.
  • 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.

Trial design

840 participants in 6 patient groups

Severe/Cerebral Malaria
Description:
Intensive monitoring
Treatment:
Other: Observation
Uncomplicated Malaria
Description:
Intensive monitoring
Treatment:
Other: Observation
Sepsis
Description:
Intensive monitoring
Treatment:
Other: Observation
Acidosis
Description:
Intensive monitoring
Treatment:
Other: Observation
Encephalitis
Description:
Intensive monitoring
Treatment:
Other: Observation
Healthy Individuals
Description:
Monitoring
Treatment:
Other: Observation

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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