Aggressive Antipyretics for Fever Reduction in CNS Malaria
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.
Timeline
- Start
- 2019-01-07
- Primary completion
- 2022-12-02
- Completion
- 2022-12-02
Outcome
Met primary endpoint
registry MEAN Aggressive Antipyretics (AA): 38.6 (38.4 to 38.7) degrees of Celsius MEAN Usual Care (UC).: 39.2 (39.1 to 39.3) degrees of Celsius NCT03399318 ↗
registry analysis (superiority test); Aggressive Antipyretics (AA) vs Usual Care (UC).; p <0.0001; t-test, 2 sided; NCT03399318 ↗
registry COUNT_OF_PARTICIPANTS Aggressive Antipyretics (AA): Multiple or Prolonged: 10 Participants COUNT_OF_PARTICIPANTS Usual Care (UC).: Multiple or Prolonged: 34 Participants NCT03399318 ↗
registry analysis (superiority test); Aggressive Antipyretics (AA) vs Usual Care (UC).; p <0.05; Odds Ratio (OR) 0.09 (95% CI .03 to .27); Regression, Logistic NCT03399318 ↗
Publications
- Birbeck GL, Seydel KB, Mwanza S, Tembo D, Chilombe M, Watts A, Ume-Ezeoke I, Mathews M, Patel AA, Mwenechanya M, Pensulo P, McDermott MP. Acetaminophen and Ibuprofen in Pediatric Central Nervous System Malaria: A Randomized Clinical Trial. JAMA Neurol. 2024 Aug 1;81(8):857-865. doi: 10.1001/jamaneurol.2024.1677.
- Tembo D, Mwanza S, Mwaba C, Dallah I, Wa Somwe S, Seydel KB, Birbeck GL. Risk factors for acute kidney injury at presentation among children with CNS malaria: a case control study. Malar J. 2022 Nov 1;21(1):310. doi: 10.1186/s12936-022-04327-y.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Acetaminophen | Small molecule | 15 mg/kg | Oral |
| Subject | Ibuprofen | Small molecule | 10 mg/kg | Oral |