| CTRI Number |
CTRI/2015/11/006360 [Registered on: 16/11/2015] Trial Registered Prospectively |
| Last Modified On: |
01/11/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effect of a drug, named dexamethasone in infection of meninges |
|
Scientific Title of Study
|
A study to assess the role of early dexamethasone therapy in prevention of morbidity and mortality in children aged 6months to 12 years with pyogenic meningitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nilay Ranjan Bagchi |
| Designation |
Associate Professor |
| Affiliation |
Medical college and hospital, kolkata |
| Address |
Dept of Paediatric Medicine
Kolkata Medical College
88 College street
kolkata
Kolkata
WEST BENGAL
700073
India |
| Phone |
9433071198 |
| Fax |
|
| Email |
nrbagchiped@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Debajyoti Datta |
| Designation |
2nd year Post graduate trainee |
| Affiliation |
Medical college and hospital, kolkata |
| Address |
Dept of Paediatric Medicine
Kolkata Medical College
88 College street
kolkata
Kolkata
WEST BENGAL
700073
India |
| Phone |
9474487900 |
| Fax |
|
| Email |
drdebajyotidatta.nrs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Debajyoti Datta |
| Designation |
2nd year Post graduate trainee |
| Affiliation |
Medical college and hospital, kolkata |
| Address |
Dept of Paediatric Medicine
Kolkata Medical College
88 College street
kolkata
WEST BENGAL
700073
India |
| Phone |
9474487900 |
| Fax |
|
| Email |
drdebajyotidatta.nrs@gmail.com |
|
|
Source of Monetary or Material Support
|
| Medical College and Hospital, kolkata, 88 College Street, Kolkata- 700073 |
|
|
Primary Sponsor
|
| Name |
Kolkata Medical College and Hospital |
| Address |
88 College Street
kolkata- 700073 |
| 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 |
| Nilay Ranjan Bagchi |
Kolkata Medical College and Hospital |
Department of Paediatric Medicine, 88 college street,
Kolkata- 700073
Kolkata
WEST BENGAL |
9433071198
nrbagchiped@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Human Research, Medical College, Kolkata |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Pyogenic Meningitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexamethasone |
0.15mg/kg/dose QDS for initial 4 days of antibiotic therapy. 1st dose of dexamethasone to be given 15 minutes before 1st dose of antibiotic |
| Comparator Agent |
Normal saline |
same volume as that of dexamethasone to be given . |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Any patient of 6 months to 12years of age with clinical manifestations of acute meningitis, CSF profile consistent with bacterial meningitis.
2. Confirmed pathogen by blood or CSF culture.
|
|
| ExclusionCriteria |
| Details |
1 Patient’s age less than 6 months or more than 12years.
2 Where CSF analysis is not done or CSF profiles were not compatible with bacterial meningitis are to be excluded.
3 Neonatal maninigitis .
4 Patients received antibiotics outside before admission.
5 CSF suggestive of viral, tubercular or fungal etiology.
6 any patient with a congenital or acquired abnormality of the central nervous system
7 a prosthetic device inserted into the central nervous system
8 previous episodes of bacterial meningitis
9 an underlying neurologic abnormality
10 a history of hypersensitivity to beta-lactam antibiotics are excluded
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mortality |
3weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Developement of seizure disorder |
3months |
| Hearing impairment |
6months |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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 4 |
|
Date of First Enrollment (India)
|
19/11/2015 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomised, double blind, parallel group single centre trial. It is an add-on study since both the group will receive the standard therapy. the trial evaluates the efficacy of early dexamethasone therapy o.15mg/kg /dose QDS for 4days before or along with antibiotic therapy in a case of pyogenic meningitis. the study is conducted in paediatric department of Kolkata medical college, west Bengal, India. The primary outcome measures will be mortality within 3weeks of treatment and secondary outcomes will be developement of seizure disorder at 3months and hearing impairment at 6 months after the disease. |