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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-06-30

Brief Summary

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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.

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Detailed Description

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Cerebral malaria (CM) affects \~3 million children each year, primarily in sub-Saharan Africa. Antimalarial medications can rapidly clear P. falciparum parasites, but mortality rates remain high (12-25%). Survivors do not escape unscathed--\~30% experience neurologic sequelae including epilepsy, behavioral disorders and gross neurologic deficits. Acute seizures occur commonly in CM and are associated with higher neurologic morbidity and mortality. Seizure management in malaria endemic regions is challenging because the available antiepileptic drugs (AED) induce respiratory suppression and assisted ventilation is unavailable. More optimal seizure control may improve neurologic outcomes in pediatric CM survivors, especially if the medication used is affordable and can be delivered safely and easily in resource limited settings. The investigators conducted a dose- escalation study detailed elsewhere (NCT01660672) to determine the optimal dose for use in this safety and feasibility study of enteral levetiracetam (LVT) for seizure control in children with CM and seizures admitted to Queen Elizabeth Central Hospital in Blantyre, Malawi. Enteral LVT given via nasogastric tube (NGT) rather than an intravenous (IV) formulation will be used since LVT has excellent enteral bioavailability and IV formations are not affordable in most malaria-endemic regions. LVT 40mg/kg followed by 30mg per kg Q12 hourly. Children admitted with cerebral malaria and seizures will be randomized to LVT vs. standard of care with phenobarbital as needed comparing seizure control, safety, and neurological outcomes.

Conditions

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Seizure Epilepsy Cerebral Malaria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oral Levetiracetam

Oral Levetiracetam administered by NG tube.

Group Type EXPERIMENTAL

Oral Levetiracetam

Intervention Type DRUG

liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days

Standard AED

Standard AED regimen

Group Type ACTIVE_COMPARATOR

Standard AED

Intervention Type DRUG

Active comparitor, Standard AED

Interventions

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Oral Levetiracetam

liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days

Intervention Type DRUG

Standard AED

Active comparitor, Standard AED

Intervention Type DRUG

Other Intervention Names

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Keppra Standard regimen of AED therapy

Eligibility Criteria

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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

Minimum Eligible Age

24 Months

Maximum Eligible Age

83 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No