A Safety and Feasibility Study of Enteral LVT vs. Standard of Care for Seizure Control in Pediatric CM

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Pediatric cerebral malaria (CM) affects more than 3 million children each year killing ~20% and leaving one third of survivors with long term neurologic and psychiatric sequelae. Seizures occur commonly with CM and are associated with an increased risk of death and neuropsychiatric disabilities. In this Malawi-based, safety and feasibility study of enteral levetiracetam in pediatric CM, the investigators will lay the groundwork for future efficacy studies aimed at improving seizure control and ultimately decreasing the neurologic morbidity of pediatric CM.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Rochester
• Collaborator: National Institute of Neurological Disorders and Stroke (NINDS)
• Treatments: Etiracetam; Levetiracetam; Piracetam

Criteria

Inclusion Criteria:

• Comatose with Blantyre Comas Score ≤ 2

• P. falciparum parasitemia via thick blood film or rapid diagnostic test

• Active seizure in past 24 hours

Exclusion Criteria:

• Serum creatinine > 2mg/dL

• Pre-admission/concomitant treatment with antiretroviral medications for HIV (ARVs), antituberculous treatments(ATTs), or chronic use of any other enzyme-inducing medications