Safety and Efficacy Study of Intravenous Immunoglobulin to Treat Japanese Encephalitis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01856205
• Date of registration: 05/05/2013
• Prospective Registration: No
• Primary sponsor: University of Liverpool
• Public title: Safety and Efficacy Study of Intravenous Immunoglobulin to Treat Japanese Encephalitis
• Scientific title: A Randomized Double Blind Placebo Controlled Trial to Assess the Safety and Efficacy of Intravenous Immunoglobulin (IVIG) in Children With Japanese Encephalitis in Nepal
• Date of first enrolment: May 2009
• Target sample size: 22
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01856205
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Nepal

Contacts

• Name: Sam Nightingale, MRCP
• Affiliation: Institute of Infection and Global Health, University of Liverpool, Apex Building, 8 West Derby Street, Liverpool, L69 7BE, UK

• Name: Ajit Rayamajhi, MBBS, MD
• Affiliation: Institute of Infection and Global Health, University of Liverpool, Liverpool, UK & Kanti Children's Hospital, Maharajgunj, Kathmandu, Nepal

• Name: Tom Solomon, MRCP, PhD
• Affiliation: Director,Institute of Infection and Global Health, University of Liverpool, Apex Building, 8 West Derby Street, Liverpool, L69 7BE, UK , Head- Liverpool Brain Infection Group

Key inclusion & exclusion 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.



Age minimum: 1 Year
Age maximum: 14 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Japanese Encephalitis

Intervention(s)

Drug: Intravenous immunoglobulin [ImmunoRel™ (batch 20081217)]

Primary Outcome(s)

Evidence of side effects of study drug such as infusion site reaction, diarrhea, rise in blood pressure and change in urinary output [Time Frame: Every 12 hours after administration of study drug upto discharge, which is on average eigth day (192 hours) of hospital admission]

Secondary Outcome(s)

Death or neurological sequelae [Time Frame: At the time of discharge, an expected average of eighth day of admission and again at 6 months after discharge]

Secondary ID(s)

IVIG607

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Kanti Children's Hospital

B.P. Koirala Institute of Health Sciences