Overview

Aggressive Antipyretics for Fever Reduction in CNS Malaria

Status:
Recruiting
Trial end date:
2022-06-30
Target enrollment:
0
Participant gender:
All
Summary
The study will examine whether prophylactic and scheduled treatment with acetaminophen and ibuprofen can decrease the maximum temperature experienced during the acute illness in children with CNS malaria.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Rochester
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Treatments:
Acetaminophen
Antipyretics
Ibuprofen
Criteria
Inclusion Criteria:

- Evidence of P. falciparum malaria infection by peripheral blood smear or rapid
diagnostic test

- CNS symptoms associated with malaria. CEREBRAL MALARIA: Impaired consciousness with a
Blantyre Coma Score (BCS)(73) ≤2 in children under 5 years or a Glasgow Coma score
(GCS) ≤10 in children ≥5 years OR CNS MALARIA: Complicated seizure(s), meaning
prolonged (>15 minutes), focal or multiple; or impaired consciousness or other
evidence of impaired consciousness (confusion, delirium) without frank coma (BCS>2,
GCS =11-14)

Exclusion Criteria:

- Circulatory failure (cold extremities, capillary refill > 3 seconds, sunken eyes, ↓
skin turgor)

- Vomiting in the past 2 hours

- Serum Cr > 1.2 mg/dL

- A history of liver disease

- Jaundice or a total bilirubin of >3.0mg/dL

- A history of gastric ulcers or gastrointestinal bleeding

- A history of thrombocytopenia or other primary hematologic disorder

- Petechiae or other clinical indications of bleeding abnormalities

- A known allergy to ibuprofen, acetaminophen, aspirin or any non-steroidal medica-tion

- Any contraindication for nasogastric tube (NGT) placement and/or delivery of enteral
medications