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Saving Brains: the Artesunate Suppository Severe Malaria Cohort

Long-term neurocognitive assessment of children following an episode of severe malaria: the artesunate suppository trial cohort

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN73295852
Enrollment
6000
Registered
2013-05-28
Start date
2013-04-15
Completion date
Unknown
Last updated
2019-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral malaria or other CNS infection Infections and Infestations Plasmodium falciparum malaria with cerebral complications

Interventions

This is a follow up study to assess the effects of malaria on brain function. No intervention is anticipated.

Sponsors

Mahidol Oxford Tropical Medicine Research Unit (MORU) (Thailand)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: TQQ+ questionnaire, socioeconomic status, clinical history, height on: 1. Surviving children originally enrolled in Study 13 2. Male or female 3. Written informed consent by legally acceptable representative (plus assent if appropriate) 4. Willingness and ability of the participants/guardians to comply with the study tests Detailed neurocognitive exams 1. ~30% stratified sample of the surviving study cohort meeting criteria above 2. TQQ positive children 3. >8 years of age (Additional inclusion criteria will apply for participants who undergo EEG and/or MRI)

Exclusion criteria

Exclusion criteria: TQQ+ 1. Signs of acute illness Detailed neurocognitive exams 1. Signs of acute illness 2. Anti-malarial injection at enrolment into Study 13 (Additional exclusion criteria will apply for participants who will undergo EEG and/or MRI)

Design outcomes

Primary

MeasureTime frame
To describe the long-term effects of cerebral malaria or other CNS infection in childhood on the prevalence of neurological deficit in a cohort re-visited 7-13 years later

Secondary

MeasureTime frame
Prevalence of neurocognitive disability 1. To compare prevalence of neurological and cognitive deficits by detailed neurocognitive exams, by status at recruitment (2000-06) 2. To compare prevalence of neurological and cognitive deficits by detailed neurocognitive exams, by treatment allocation at recruitment and, where possible, by time to reach a health facility (2000-06) 3. To compare prevalence of neurological and cognitive deficits by detailed neurocognitive exam, by status at follow-up (2013-14) 4. To quantify types of disability by each separate neurocognitive test Characterising neurological disability 1. To confirm and characterise the type of neurological damage by electro-encephalogram (EEG) 2. To confirm and characterise neurological damage by magnetic resonance imaging (MRI) Development of screening tools 1. Develop and validate core metrics and neuro-development and cognitive instruments to measure neurocognitive disability in participating sites 2. Map using GPS all study participants? houses

Countries

Bangladesh, Ghana, Tanzania

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026