| CTRI Number |
CTRI/2024/12/078773 [Registered on: 30/12/2024] Trial Registered Prospectively |
| Last Modified On: |
27/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of ribavirin in children with infection of brain |
|
Scientific Title of Study
|
Evaluation of efficacy of add on oral ribavirin in children with acute viral encephalitis aged 1-18 years: an open labelled randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prateek Kumar Panda |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
6th Floor, Department of Pediatrics
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9650149735 |
| Fax |
|
| Email |
drprateekpanda@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prateek Kumar Panda |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
6th Floor, Department of Pediatrics
UTTARANCHAL
249203
India |
| Phone |
9650149735 |
| Fax |
|
| Email |
drprateekpanda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prateek Kumar Panda |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
6th Floor, Department of Pediatrics
UTTARANCHAL
249203
India |
| Phone |
9650149735 |
| Fax |
|
| Email |
drprateekpanda@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Virbhadra Nagar, Rishikesh, Pin-249203, Uttarakhand, India |
|
|
Primary Sponsor
|
| Name |
Dr Prateek Kumar Panda |
| Address |
6th Floor, Department of Pediatrics, AIIMS, Rishikesh, District-Dehradun, Uttarakhand, India, Pin code-249203 |
| Type of Sponsor |
Other [Self] |
|
|
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 Prateek Kumar Panda |
All India Institute of Medical Sciences, Rishikesh |
6th Floor, Department of Pediatrics
Dehradun
UTTARANCHAL |
9650149735
drprateekpanda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences, 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 |
acyclovir |
30 mg/kg/day daily in three divided doses intravenously for seven days |
| Intervention |
Ribavirin |
10 mg/kg/day daily orally tablets in four divided doses for seven days |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children with diagnosis of viral encephalitis |
|
| ExclusionCriteria |
| Details |
Children with chronic major systemic illness
Previous documented allergy to ribavirin |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Survival without severe disability |
At 3 months after randomization |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Cognition of each participant as measured by the Vineland Social Maturity Scale |
At 3 months follow up after completing the seven day course of study medication |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 2 |
|
Date of First Enrollment (India)
|
15/01/2025 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This open-labeled randomized controlled trial will compare the efficacy of add-on oral ribavirin in children aged 1-18 years, with viral encephalitis. The intervention group will receive add-on oral ribavirin for seven days. The control group will receive only intravenous acyclovir for seven days. We will compare the survival rate without severe disability and the duration of hospitalization in both groups. |