Aggressive Antipyretics for Fever Reduction in CNS Malaria
- Conditions
- MalariaPaediatrics
- Registration Number
- PACTR201804003255157
- Lead Sponsor
- niversity of Rochester
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 284
1. Evidence of P. falciparum malaria infection by peripheral blood smear or rapid diagnostic test.
2. CNS symptoms associated with malaria. Cerebral malaria: Impaired consciousness with a Blantyre Coma Score (BCS)(73)less than or equal to 2 in children under 5 yrs or a Glasgow Coma Score (GCS)less than or equal to 10 in children greater than or equal to 5 yrs 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).
1. Circulatory failure (cold extremities, capillary refill > 3 seconds, sunken eyes, decreased skin turgor).
2. Vomiting in the past 2 hrs.
3. Serum Cr> 1.2 mg/dL.
4. A hx of liver disease.
5. Jaundice or a total bilirubin of >3.0mg/dL.
6. A hx of gastric ulcers or gastrointestinal bleeding.
7. A hx of thrombocytopenia or other primary hematologic disorder.
8. Petechiae or other clinical indications of bleeding abnormalities.
9. A known allergy to ibuprofen, acetaminophen, aspirin or any non-steroidal medication.
10. Any contraindication for nasogastric tube (NGT) placement and/or delivery of enteral medications.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method