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Efficacy of add on oral minocycline in children with acute encephalitis syndrome aged 1 month-18 years

Phase 3
Conditions
Health Condition 1: G049- Encephalitis, myelitis and encephalomyelitis, unspecified
Registration Number
CTRI/2024/07/070172
Lead Sponsor
All India Institute of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1.Children between age 1 month-18 years of age

2. Presenting to department of pediatrics, AIIMS Rishikesh with a clinical diagnosis of acute encephalitis syndrome

3. Parents willing to comply with the study protocol and follow up

Exclusion Criteria

1.Preexisting major chronic systemic illness including cardiovascular, respiratory, gastrointestinal system or chronic renal disease

2.Preexisting developmental delay or intellectual disability

3.Definite diagnosis of neurometabolic or neurodegenerative disease

4.Caregivers not giving informed consent

5.History of allergy to minocycline previously

6.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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The primary outcome is change in FSS scale score at 12 weeks as compared to baseline.Timepoint: baseline and 12 weeks
Secondary Outcome Measures
NameTimeMethod
change in Glassgow coma scaleTimepoint: day0, day7 and 12 weeks;Change in Paediatric cerebral performance category scoreTimepoint: baseline day 7 and day 12;Childhood Behavioural ChecklistTimepoint: 12 weeks <br/ ><br>;duration of hospitalisationTimepoint: 12 weeks <br/ ><br>;mortalityTimepoint: day 7 and 12 weeks <br/ ><br>;PedsQL scoreTimepoint: 12 weeks;Vineland adaptive behavior scoreTimepoint: 12 weeks <br/ ><br>;Vineland social maturity scoreTimepoint: 12 weeks
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