Health Condition 1: G049- Encephalitis, myelitis and encephalomyelitis, unspecified
Conditions
Interventions
Intervention1: Intravenous azithromycin: Intravenous Azithromycin would be given in the dose of 10mg/kg over 5 days in addition to conventional treatment
Control Intervention1: conventional treatment
Sponsors
KUNDAN MITTAL
Eligibility
Inclusion criteria
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
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of children who expired (Mortality)Timepoint: during hospital stay upto discharge | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 3. Degree of impairment in terms of International Classification of Functioning, Disability, and Health-Children and Youth Version (ICF-CY) 4. Total length of hospital stay in daysTimepoint: AT TIME OF DISCHARGE | — |
Countries
India
Contacts
Public ContactPRITI YADAV
PT BD SHARMA PGIMS ROHTAK
Outcome results
None listed