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

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) - MAES trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/070172
Enrollment
130
Registered
2024-07-08
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G049- Encephalitis, myelitis and encephalomyelitis, unspecified

Interventions

Intervention1: Tab Minocycline: Add on oral minocycline through nasogastric tube for 7 days at a loading dose of 5 mg/kg/day followed by 2·5 mg/kg 12 hourly in children up to 12 years old and 200 mg l

Sponsors

All India Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
The primary outcome is change in FSS scale score at 12 weeks as compared to baseline.Timepoint: baseline and 12 weeks

Secondary

MeasureTime frame
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 ;duration of hospitalisationTimepoint: 12 weeks ;mortalityTimepoint: day 7 and 12 weeks ;PedsQL scoreTimepoint: 12 weeks;Vineland adaptive behavior scoreTimepoint: 12 weeks ;Vineland social maturity scoreTimepoint: 12 weeks

Countries

India

Contacts

Public ContactDr Indar Kumar Sharawat

All India institute of Medical Sciences, Rishikesh

sherawatdrindar@gmail.com9560182301

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026