NIH Reporter #3R34AI198088-01S4

Aggressive antipyretics for neuroprotection and mortality reduction in CNS malaria: A Randomized-Controlled Trial

This award funds a randomized controlled trial to test aggressive antipyretic therapy to reduce mortality and neurological morbidity in children with CNS malaria, supporting preparations for a phase III trial.

Description

The trial will test adjunctive aggressive antipyretic therapy (AAA) using maximal dose, scheduled ibuprofen and acetaminophen to reduce mortality and neurological morbidity in children with CNS malaria. The project aims to facilitate preparations for a phase III trial, including capacity building, translation, piloting of outcome instruments, and regulatory approvals. The intervention involves administering AAA therapy for 72 hours versus usual care. The primary outcome is time to death, neurodisability, or epilepsy. The trial will exclude children with moderate or worse acute kidney injury and pre-existing neurodisabilities or epilepsy. The project involves a multi-national, randomized controlled trial in Malawi, Zambia, and DRC. The intervention is cost-effective and sustainable, utilizing widely available agents. The project includes logistical preparations, capacity building, and regulatory processes.

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