Status:
COMPLETED
Safety and Efficacy Study of Intravenous Immunoglobulin to Treat Japanese Encephalitis
Lead Sponsor:
University of Liverpool
Collaborating Sponsors:
Kanti Children's Hospital
B.P. Koirala Institute of Health Sciences
Conditions:
Japanese Encephalitis
Eligibility:
All Genders
1-14 years
Phase:
PHASE2
Brief Summary
Japanese encephalitis is caused by a viral infection of the brain transmitted by the bite of an infected mosquito. Patients with Japanese encephalitis can rapidly develop worsening conscious level and...
Detailed Description
Japanese encephalitis (JE) is the most important epidemic encephalitis worldwide, causing approximately 35-50,000 cases and 10-15,000 deaths annually. Half of the survivors have severe neuropsychiatri...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01856205
Start Date
May 1 2009
End Date
August 1 2009
Last Update
May 21 2013
Active Locations (2)
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1
Kanti Children's Hospital
Kathmandu, Bagmati, Nepal, 44616
2
BP Koirala Institute of Health Sciences
Dharān, Koshi, Nepal