Status:
COMPLETED
Aggressive Antipyretics for Fever Reduction in CNS Malaria
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Malaria
Seizures
Eligibility:
All Genders
2-11 years
Phase:
PHASE2
Brief 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 mala...
Detailed Description
Despite ongoing eradication efforts, malaria remains a major public health challenge in Africa where annually, \~250,000 children with malaria experience a neurologic injury with subsequent neurodisab...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 2 2022
Estimated Enrollment :
256 Patients enrolled
Trial Details
Trial ID
NCT03399318
Start Date
January 7 2019
End Date
December 2 2022
Last Update
March 5 2024
Active Locations (3)
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1
Pediatric Research Ward at Queen Elizabeth Central Hospital
Blantyre, Malawi
2
Chipata Central Hospital
Chipata, Eastern Province, Zambia
3
University Teaching Hospital's Lusaka Childrens Hospital
Lusaka, Zambia