Severe Plasmodium falciparum malaria Infections and Infestations
Conditions
Interventions
Current interventions as of 18/08/2025:
The primary aim is to characterise the contemporary epidemiology (including features at presentation, diagnostic and treatment pathway) of severe malaria in c
characterise time from presentation to the hospital ‘gateway’ to ward admission and time to first dose of parenteral artesunate to assess whether delays in definitive treatment may underpin malaria se
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Children aged 3 months to 15 years 2. Admitted to hospital with P. falciparum malaria defined by a positive ParacheckTM rapid diagnostic test 3. History of fever by self-report or documented abnormal temperature at screening (fever or hypothermia, axillary temperature >37.5°C or <36°C) 4. Caregiver provides written informed consent, including for 6-month follow-up for severe malaria cases and non-severe malaria controls 5. Cases are defined as having either one or more of World Health Organization (WHO) Group 1 or 2 severity features or Teule Criteria 5.1. WHO clinical severity features include 5.1.1. Impaired consciousness: prostration (also Teule criteria) or coma 5.1.2. 2 or more convulsions within the last 24 hours 5.1.3. Respiratory distress (also Teule criteria) 5.1.4. Compensated or decompensated shock 5.1.4.1. Compensated shock is defined as capillary refill =3 s or temperature gradient on leg (mid to proximal limb), but no hypotension 5.1.4.2. Decompensated shock (hypotension) is defined as systolic blood pressure <70 mm Hg in children 5.1.5. Jaundice 5.1.6. Dark or cola coloured urine (blackwater fever) 5.2. WHO laboratory severity criteria, consisting of 5.2.1. Haemoglobin <5g/dl (also Teule criteria) (if routinely done) 5.3. Teule criteria consist of one or more of 5.3.1. HIV (standard test for all hospitalised children) 5.3.2. Impaired consciousness: prostration or coma (also WHO clinical criteria) 5.3.3. Respiratory distress (also WHO clinical criteria) 5.3.4. Haemoglobin <5g/dl (if routinely done) (also WHO clinical criteria) For practicality, and to reduce potential bias, recruitment of controls (children admitted with malaria without the above features) will occur on Mondays and Thursdays only
Exclusion criteria
Exclusion criteria: 1. Already enrolled into a clinical trial 2. Previously enrolled in this observational study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 17/10/2025: Data collected from patient records were used to measure: In the SMAART study: 1. Mortality: in-hospital or subsequently through 6 months post-discharge (all-cause) and 2. Readmission to hospital within 6 months of enrolment, all-causes, and with a positive malaria rapid diagnostic test (RDT) In the SMAART CHARISMA substudy: 1. Length of hospital stay (hours/days) Previous primary outcome measure: Measured using patient records: 1. Mortality: in-hospital or subsequently through 6 months post-discharge (all-cause) and 2. Readmission to hospital within 6 months of enrolment, all-causes, and with a positive malaria rapid diagnostic test (RDT) | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measure as of 17/10/2025: 1. New episodes of potential malaria, defined by self-reported anti-malarial use, self-reported positive malaria rapid diagnostic test (RDT), and self-reported febrile illnesses at follow-up (both SMAART and SMAART CHARISMA) 2. In the Soroti and Kalongo sites, the prevalence of Kelch Mutations will be measured along with lactate clearance and parasite clearance of ring stage parasites 3. Transfusion requirement (SMAART CHARISMA) In the SMAART CHARISMA substudy, the following safety outcomes are measured from patient records: 1. Mortality: in-hospital or subsequently through 6 months post-discharge (all-cause) 2. Readmission to hospital within 6 months of enrolment all causes, and with a positive malaria rapid diagnostic test (RDT) Previous secondary outcome measure: 1. New episodes of potential malaria, defined by self-reported anti-malarial use, self-reported positive malaria rapid diagnostic test (RDT), and self-reported febrile illnesses at follow-up 2. In the Soroti and Kalongo sites, the prevalence of Kelch Mutations will be measured along with lactate clearance and parasite clearance of ring stage parasites | — |
Countries
Ghana, Kenya, Mozambique, Uganda, Zambia
Contacts
Public ContactEmmanuel Oguda
Outcome results
None listed