At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 57 enrolled
Drug / intervention
Hypertonic saline +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Treating Brain Swelling in Pediatric Cerebral Malaria
In Brief
A Phase 3 clinical trial evaluating Mechanical ventilation and Hypertonic saline for Malaria, Cerebral. Completed, enrolled 57 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalaria, Cerebral
CountriesMalawi
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedOct 2017
Enrollment StartJan 2018
Primary CompletionDec 2023
TodayJul 2026
First PostedOct 3, 2017
Enrollment StartJan 8, 2018
Primary CompletionDec 31, 2023
TodayJul 2, 2026
Enrollment to primary: 6.0 yearsPosted 8.7 years ago
Interventions
Mechanical ventilationother
Intubation and mechanical ventilation for a maximum of 7 days
Hypertonic salinedrug
Intravenous 3 percent hypertonic saline for a maximum of 7 days