A study to compare effect of azithromycin versus empirical treatment in acute encephalitis syndrome
- Conditions
- Health Condition 1: G049- Encephalitis, myelitis and encephalomyelitis, unspecified
- Registration Number
- CTRI/2020/05/025270
- Lead Sponsor
- KUNDAN MITTA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
- Children with prior developmental delay or intellectual disability
- Children with known renal, pulmonary, cardiac or hepatic dysfunction.
- 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)Timepoint: 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 <br/ ><br>2. Proportion of children with at least one serious adverse event <br/ ><br>3. Degree of impairment in terms of International Classification of Functioning, Disability, and Health-Children and Youth Version (ICF-CY) <br/ ><br>4. Total length of hospital stay in daysTimepoint: AT TIME OF DISCHARGE