Evaluation of efficacy of add on oral minocycline in children with Acute Encephalitis Syndrome aged 1 month-18 years: a open-labelled randomized controlled trial (MAES trial)
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Enrollment
- 130
- Locations
- 1
- Primary Endpoint
- The primary outcome is change in FSS scale score at 12 weeks as compared to baseline.
Study Overview
Brief Summary
A definitive and dramatic cure is not available for most cases of AES. A significant proportion of patients with AES develop short term and long term adaptive, cognitive and behavioral impairment. Minocycline is a semisynthetic tetracycline, which is safe and approved for human use. It is lipophilic, acts as a neuroprotective agent and in animal models have been shown to be efficacious against reovirus, West Nile virus, HIV and JEV. The hypothesis is Add on oral minocycline being more efficacious in improving the functional status of children aged 1 month to 18 years at 12 weeks as compared to standard treatment alone.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 1.00 Month(s) to 18.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Children between age 1 month-18 years of age
- •Presenting to department of pediatrics, AIIMS Rishikesh with a clinical diagnosis of acute encephalitis syndrome
- •Parents willing to comply with the study protocol and follow up.
Exclusion Criteria
- •Preexisting major chronic systemic illness including cardiovascular, respiratory, gastrointestinal system or chronic renal disease
- •Preexisting developmental delay or intellectual disability
- •Definite diagnosis of neurometabolic or neurodegenerative disease
- •Caregivers not giving informed consent
- •History of allergy to minocycline previously
- •Children in whom Minocycline can’t be administered orally or through nasogastric tube within 72 hours of presenting to our institute due to clinical contraindications.
Outcomes
Primary Outcomes
The primary outcome is change in FSS scale score at 12 weeks as compared to baseline.
Time Frame: baseline and 12 weeks
Secondary Outcomes
- change in Glassgow coma scale(day0, day7 and 12 weeks)
- Change in Paediatric cerebral performance category score(baseline day 7 and day 12)
- mortality(day 7 and 12 weeks)
- duration of hospitalisation(12 weeks)
- PedsQL score(12 weeks)
- Vineland social maturity score(12 weeks)
- Childhood Behavioural Checklist(12 weeks)
- Vineland adaptive behavior score(12 weeks)
Investigators
Tanisha Gupta
All India institute of Medical Sciences, Rishikesh