Aggressive Antipyretics for Fever Reduction in CNS Malaria (NCT03399318) | Clinical Trial Compass
CompletedPhase 2
Aggressive Antipyretics for Fever Reduction in CNS Malaria
Malawi, Zambia256 participantsStarted 2019-01-07
Plain-language 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.
Who can participate
Age range2 Years – 11 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Evidence of Plasmodium falciparum malaria infection by peripheral blood smear or rapid diagnostic test
* Central nervous system (CNS) symptoms associated with malaria. CEREBRAL MALARIA (CM): 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 creatinine (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 medication
* Any contraindication for nasogastric tube (NGT) placement and/or delivery of enteral medications