Duration of Anti-convulsant Therapy for Acute Symptomatic Seizure in Acute Encephalitis Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-01

Study Completion Date

2019-02-28

Brief Summary

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There are no guidelines or studies evaluating duration of anti-epileptic drugs in central nervous system infections. The duration of anti-epileptic drug is extrapolated from traumatic brain injury in which duration of 1 weeks to 3 months is suggested. So the investigators plan to conduct this study to decide the optimal duration of anti-epileptic drug in acute symptomatic seizure in central nervous system infections

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Detailed Description

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Demography data, seizure details at diagnosis of acute encephalitis syndrome, details of etiology, neuroimaging findings and electroencephalography. A detailed neurological examination will be done in all participants and asked for seizure semiology at admission. Seizure details include seizure type, duration, number of seizures, number of days for which seizures were recurring, status epilepticus, encephalopathy in between seizures. After the initial assessment participants would be randomized into 2 groups: Group 1: Anti-epileptic drug for 4 weeks followed by taper in 10-14days and Group 2: Anti-epileptic drug for 12 weeks followed by tapering over 10-14days. The primary outcome would be be to study the seizure relapse rate (proportion) after stopping anti-epileptic drugs in participants with acute symptomatic seizure given 4weeks and 12 weeks anti-epileptic drug therapy in the two study groups.

Clinical status will be assessed at enrollment as defined by Pediatric Cerebral Performance Category, Pediatric overall Performance Category and Glasgow Outcome Scale-Extended Pediatric Version (GOS-P)

Conditions

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Seizures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Whether 4 weeks anti-epileptic drug is as efficacious as 12 weeks anti-epileptic drug therapy for Acute Encephalitis syndrome

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Open label study

Study Groups

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Group 4 weeks

Anti-epileptic drug (as used by treating physician for management of acute symptomatic seizure) for 4 weeks followed by taper in 10-14days

Group Type ACTIVE_COMPARATOR

Group 4 weeks

Intervention Type OTHER

Anti-epileptic drug (as used by treating physician for management of acute symptomatic seizure) for 4 weeks followed by taper in 10-14days

Group 12 weeks

Anti-epileptic drug (as used by treating physician for management of acute symptomatic seizure) for 12 weeks followed by taper in 10-14days

Group Type ACTIVE_COMPARATOR

Group 12 weeks

Intervention Type OTHER

Anti-epileptic drug (as used by treating physician for management of acute symptomatic seizure) for 12 weeks followed by taper in 10-14days

Interventions

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Group 4 weeks

Anti-epileptic drug (as used by treating physician for management of acute symptomatic seizure) for 4 weeks followed by taper in 10-14days

Intervention Type OTHER

Group 12 weeks

Anti-epileptic drug (as used by treating physician for management of acute symptomatic seizure) for 12 weeks followed by taper in 10-14days

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Children with acute encephalitis syndrome with acute symptomatic seizures on single anti-epileptic drug will be enrolled in Out patient clinic at 4 weeks of illness

Exclusion Criteria

* Children with chronic meningitis, brain abscess, intracranial Space occupying lesion
* Children with prior history of seizures, prior focal neurological deficit
* Children with abnormal development prior to development of seizures
* HIV, Chronic Liver disease, Chronic Kidney disease, acute hepatic encephalopathy
* Children on two or more than 2 anti-epileptic drugs
* Severely affected children (Pediatric Cerebral Performance Category Scale (PCPC) Score, Pediatric Overall Performance Category Scale with category score of 5)
* Refusal of consent

Minimum Eligible Age

3 Months

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No