A study to compare effect of azithromycin versus empirical treatment in acute encephalitis syndrome

Not yet recruiting

Conditions: Encephalitis, myelitis and encephalomyelitis, unspecified,

Registration Number: CTRI/2020/05/025270

Lead Sponsor: KUNDAN MITTAL

Brief Summary: The eligibleparticipants will be enrolled consecutively. A predesigned case record formwill be filled. Each eligible child will be subjected todemographic details (age, gender, socioeconomic status). A detailed historywill be recorded. Complete neurological examination would be performed. Alleligible participants would be admitted in Pediatric Intensive Care Unit.Management of children with acute encephalitis would be as per the standardprotocol. Eligible participants would be randomized into interventionalgroup (Azithromycin plus conventional treatment) and control group(conventional treatment).

Intervention group will be given Azithromycin plusconventional treatment and in control group only conventional treatment will be given.

Intravenous Azithromycinwould be given in the dose of 10mg/kg over 5 days. Adverse events if any wouldbe managed symptomatically and recorded. Conventionalempirical treatment of acute encephalitis syndrome will be as per the consensusguidelines on evaluation and management of suspected acute encephalitis inchildren in India.

**1.** Managementof seizures with anti epileptic medication.

**2.** Managementto decrease raised intracranial pressure:3% Nacl or Mannitol

**3.** Antimicrobialprotocol:

a.      Intravenous Ceftriaxone (100mg/kg/day in 2 divided doses)

b.     Intravenous Vancomycin (60 mg/kg/dayin 4 divided doses)

c.      Intravenous acyclovir (20 mg/kg/doseevery 8 hours) [To be stopped once CSF HSV PCR is negative]

d.     IV artesunate: 2.4-3 mg/kg once a day to be stopped if peripheralsmear for malarial parasite is negative

**4.** Management ofassociated systemic complication as per standard PICU protocol.

Vital signsincluding heart rate, respiratory rate, mean arterial pressure would berecorded at least every 6 hourly. Level of consciousness in terms of Glasgowcoma score and four scores will be evaluated every 6 hourly respiratorypattern, presence of oculo cephalic reflex, pupil size and reaction, brainstemfunction, fundus evaluation would be recorded at-least every 12 hourly. Needfor mechanical ventilation, need for inotropic support, evidence of multi-organdysfunction would be recorded. Once the patient is hemodynamically stable and feedinghas been established, the patient would be shifted to the ward. Any adverseevent following drug administration would be recorded. Common adverse eventsthat would be recorded include fever, dyspnea, vomiting, irritable, skin rash,hypotension, Malena.

Neuroimaging including MRI Brain and EEG would beperformed as soon as the patient is hemodynamically stable. Blood sample wouldbe obtained for ELISA for scrub typhus, HIV serology and for obtaining thickand thin peripheral smear for malarial parasite. Cerebrospinal fluid (CSF) [5ml] would be obtained for testing for Japanese encephalitis using ELISA.Glasgow coma score, FOUR scores, Liverpool outcome score, ICF-CY scoring willbe performed at the time of discharge.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

Presence of altered mental status with at least three of the following: fever (>38 C) lasting for more than 72 hours before or after presentation; generalized or focal seizure not attributable to preexisting seizure disorder; new onset of focal neurological deficit; CSF pleocytosis> 5/cumm; abnormality of brain parenchyma on neuro imaging suggestive of encephalitis that is acute in onset or new from prior studies; abnormality on electroencephalography that is consistent with encephalitis and not attributable to another cause, coma, or inability to talk.

Exclusion Criteria

Children with prior developmental delay or intellectual disability.
Children with suspected inborn errors of metabolism.
Children with toxic encephalopathy or traumatic brain injury.
Children who have hemorrhagic or ischemic stroke.
Children with clinical and laboratory evidence of multi-organ dysfunction at hospital admission.
Children who have already received treatment other than conventional treatment including Azithromycin or steroids.
Children having high clinical suspicion of bacterial meningitis or TB meningitis.
Children with a contraindication to Azithromycin or albumin.
Children with known hyper coagulable state.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of children who expired (Mortality)	during hospital stay upto discharge

Secondary Outcome Measures

Name	Time	Method
1. Proportion of children with significant disability as determined by Liverpool outcome score (LOS) at discharge	2. Proportion of children with at least one serious adverse event

Trial Locations

Locations (1): Pt B D Sharma Postgraduate Institute of Medical Sciences, Rohtak
🇮🇳
Rohtak, HARYANA, India
Pt B D Sharma Postgraduate Institute of Medical Sciences, Rohtak
🇮🇳Rohtak, HARYANA, India
PRITI YADAV
Principal investigator
7838754501
prityadav12@gmail.com