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