Phase 3
N=57
Treating Brain Swelling in Pediatric Cerebral Malaria
Malaria, Cerebral
Bottom Line
View on ClinicalTrials.gov: NCT03300648 ↗Enrolled (actual)
57
Serious AEs
12.3%
Results posted
Mar 2025
Primary outcome: Primary: Number of Participants Who Died — 5; 5; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Mechanical ventilation (Other); Hypertonic saline (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Michigan State University
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Died |
5; 5; 5 | — |
| SECONDARY Neurodevelopmental Disability |
5; 4; 1 | — |
Summary
This study evaluates the effectiveness of two interventions in Malawian children with cerebral malaria at high risk of death. One-third of the participants will receive treatment as usual, one-third will receive treatment as usual and be placed on a mechanical ventilator, and one-third will receive treatment as usual plus intravenous hypertonic saline.
Eligibility Criteria
Inclusion Criteria
- Peripheral P. falciparum parasitemia of any density
- Blantyre Coma Score ≤2
- No evidence of meningitis on lumbar puncture
- Consciousness not regained after correction of hypoglycemia (if hypoglycemia is present)
- Male or female whose age on the day of screening is between 6 months and 12 years old
- Severely increased brain volume on magnetic resonance imaging
- Provision of consent by guardian
- Willingness to return for 1, 6, and 12 month post-randomization follow-up visits
Exclusion Criteria
- Gross malnutrition as evidenced by peripheral edema, hair color changes, or severe wasting
- Advanced Human Immunodeficiency Virus (HIV) disease - defined as known HIV positive status and evidence of severe wasting
- Evidence of recent head trauma by history or physical examination
- Pneumonia as evidenced by oxygen saturation on room air of 3 seconds or skin tenting
Data sourced from ClinicalTrials.gov (NCT03300648). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.