Safety and Efficacy Study of Intravenous Immunoglobulin to Treat Japanese Encephalitis
Japanese Encephalitis
About this trial
This is an interventional treatment trial for Japanese Encephalitis focused on measuring Japanese Encephalitis, Randomized Controlled Trial, intravenous immunoglobulin, safety, efficacy, Nepal
Eligibility Criteria
Inclusion Criteria:
- Children aged between 1 and 14 years who had clinically diagnosed encephalitis on the basis of history of fever that lasted less than 14 days, altered consciousness with or without a history of new onset seizures with CSF finding of white cell count less than 1000 cells/mm3 with no organisms on Gram stain and a CSF: plasma glucose ratio > 40% admitted in Kanti Children's Hospital and BP Koirala Institute of Health Sciences, Nepal.
Exclusion Criteria:
Asexual Plasmodium falciparum parasites in blood
- Coma appears secondary to other systemic condition, eg hepatic failure, cardiac failure, toxins.
- Patients who have documented antibiotic treatment before admission and in whom partially treated bacterial meningitis appears more likely than encephalitis
- Children with simple febrile convulsions, defined as a single seizure lasting less than 15 minutes followed by full recovery of consciousness within 60 minutes.
- Pregnant or breastfeeding females
- Children with a GCS of 3/15, who were receiving artificial ventilation without signs of spontaneous respiration, and with absent oculocephalic reflex.
Sites / Locations
- Kanti Children's Hospital
- BP Koirala Institute of Health Sciences
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Placebo Comparator
IVIG in JE (JE-positive)
IVIG in Non-JE(JE-negative)
We randomly allocated patients to treatment with IVIG or placebo. Children received either saline or intravenous immunoglobulin (IVIG) [ImmunoRel™ (batch 20081217)] at a dose of 400mg/kg/day for 5 days or an equivalent volume of 0.9% normal saline given intravenous at the rate of 0.01 to 0.02 ml/kg body weight/minute. All investigators, care providers and participants were blinded of the study drug. A second sealed envelope was kept with the patient's notes in case a physician urgently needed to know which drug a patient had received.
We randomly allocated patients to treatment with IVIG or placebo. Children received either saline or intravenous immunoglobulin (IVIG) [ImmunoRel™ (batch 20081217)] at a dose of 400mg/kg/day for 5 days or an equivalent volume of 0.9% normal saline given intravenous at the rate of 0.01 to 0.02 ml/kg body weight/minute. All investigators, care providers and participants were blinded of the study drug. A second sealed envelope was kept with the patient's notes in case a physician urgently needed to know which drug a patient had received.