CompletedPhase 3

Treating Brain Swelling in Pediatric Cerebral Malaria

Malawi57 participantsStarted 2018-01-08

Plain-language 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.

Who can participate

Age range

6 Months – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 \<85% * Gastroenteritis and shock as evidenced by capillary refill \>3 seconds or skin tenting

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants Who Died

Timeframe: Within 7 days of randomization

Trial details

NCT IDNCT03300648

SponsorMichigan State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-31

Results submitted2025-01-30

View on ClinicalTrials.gov More Malaria, Cerebral trials