| CTRI Number |
CTRI/2024/07/070172 [Registered on: 08/07/2024] Trial Registered Prospectively |
| Last Modified On: |
08/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of add on oral minocycline in children with acute encephalitis syndrome aged 1 month-18 years |
|
Scientific Title of Study
|
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 Acronym |
MAES trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tanisha Gupta |
| Designation |
Postgraduate resident |
| Affiliation |
All India institute of Medical Sciences, Rishikesh |
| Address |
Junior Resident, Department of Paediatrics, AIIMS, Rishikesh
193 D, Urban estate, Phase 1, Focal Point, Ludhiana-141010
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8427311705 |
| Fax |
|
| Email |
gupta.tani1512@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Indar Kumar Sharawat |
| Designation |
Additional Professor |
| Affiliation |
All India institute of Medical Sciences, Rishikesh |
| Address |
Department of Paediatrics, AIIMS, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9560182301 |
| Fax |
|
| Email |
sherawatdrindar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Indar Kumar Sharawat |
| Designation |
Additional Professor |
| Affiliation |
All India institute of Medical Sciences, Rishikesh |
| Address |
Department of Paediatrics, AIIMS, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9560182301 |
| Fax |
|
| Email |
sherawatdrindar@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India institute of medical sciences, Virbhadra road, shivaji nagar, near barage, Rishikesh, Uttrakhand, India- 249203 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Department of pediatrics, AIIMS, Virbhadra road, shivaji Nagar, Near Barage, Rishikesh, Uttrakhand, India- 249203 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Tanisha Gupta |
AIIMS, rishikesh |
Department of Pediatrics, AIIMS, rishikesh
Dehradun
UTTARANCHAL |
8427311705
gupta.tani1512@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS,rishikesh, Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G049||Encephalitis, myelitis and encephalomyelitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard care |
Both the arms will be continued on standard of care treatment for acute encephalitis syndrome |
| Intervention |
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 loading dose followed by 100 mg 12 hourly in older patients, along with standard care of treatment for AES. (for 7 days) |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome is change in FSS scale score at 12 weeks as compared to baseline. |
baseline and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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
|
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
19/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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.
|