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Aggressive Antipyretics for Fever Reduction in CNS Malaria

Not Applicable
Conditions
Malaria
Paediatrics
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
Inclusion Criteria

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).

Exclusion Criteria

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
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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