| CTRI Number |
CTRI/2024/11/076811 [Registered on: 14/11/2024] Trial Registered Prospectively |
| Last Modified On: |
09/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Feasibility parallel-group randomized controlled trial with the intervention of corticosteroids in hospitalised participants with Dengue |
|
Scientific Title of Study
|
Protocol for a seamless phase2-3 parallel group randomized controlled trial of
corticosteroids in dengue |
| 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 Bharath Kumar |
| Designation |
Senior Consultant |
| Affiliation |
Apollo Hospital ,Chennai |
| Address |
Greams Lane, 21, Greams Rd, Thousand Lights West, Thousand Lights, Chennai, Tamil Nadu
Chennai
TAMIL NADU
600006
India |
| Phone |
919591100655 |
| Fax |
|
| Email |
bharath@icuconsultants.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bharath Kumar |
| Designation |
Senior Consultant |
| Affiliation |
Apollo Hospital ,Chennai |
| Address |
Greams Lane, 21, Greams Rd, Thousand Lights West, Thousand Lights, Chennai, Tamil Nadu
TAMIL NADU
600006
India |
| Phone |
919591100655 |
| Fax |
|
| Email |
bharath@icuconsultants.com |
|
Details of Contact Person
Public Query
|
| Name |
Shani S Thankachen |
| Designation |
Project Manager |
| Affiliation |
George Institute for Global Health |
| Address |
The George Institute for Global Health
308, Third Floor, Elegance Tower
Plot No. 8, Jasola District Centre
New Delhi
New Delhi
DELHI
110025
India |
| Phone |
91990605537 |
| Fax |
|
| Email |
sthankachen@georgeinstitute.org.in |
|
|
Source of Monetary or Material Support
|
| The George Institute for Global Health Australia |
|
|
Primary Sponsor
|
| Name |
George Institute for Global Health, Australia |
| Address |
The George Institute for Global Health
308, Third Floor, Elegance Tower
Plot No. 8, Jasola District Centre
New Delhi 110025
|
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Urvi Shukla |
Aditya Birla Memorial Hospital |
Aditya birla hospital marg
Thergaon pimpri-chinchwad
Pune
MAHARASHTRA |
9881123006
shuklaurvi@yahoo.com |
| Dr Balaji Rajaram |
Apollo Hospital Chennai |
Greams Road Chennai
Chennai
TAMIL NADU |
918098010637
balajirajaram@icuconsultants.com |
| Dr Pratheema Ramachandran |
Apollo Speciality Hospital OMR |
5/639 Rajiv Gandhi
salai Tirumalai nagar
Perungudi
Chennai
TAMIL NADU |
918069991000
pratheema@icuconsultants.com |
| Dr Ebenezer Rabindrarajan |
Apollo Speciality Hospital Vanagaram |
plot no 64
vanagaram Ambattur road
ayanambakkam
industrial estate
Chennai
TAMIL NADU |
918069991000
ebenezer@icuconsultants.com |
| Dr Jignesh Shah |
Bharati vidyapeeth Hospital |
Bharati Vidyapeeth Educational Campus, Pune-Satara Road, Pune-411 043, Maharashtra, India
Pune
MAHARASHTRA |
912024373226
jignesh.shah@bharatividyapeeth.edu |
| Dr Gerard Gonsalvez |
Kamakshi Memorial Hospital |
Dandeeswarar nagar
rose avenue
pallkaranai, Chennai
Chennai
TAMIL NADU |
04466300300
gonsalvezgerard@gmail.com |
| Dr Aravinth Srinivas |
Manipal Hospital, New delhi |
Manipal Hospital, Sector 6 Dwarka, Dwarka, Delhi, 110075
South West
DELHI |
01149674967
draravinth20@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth Deemed University Institutional Ethics Committee |
Approved |
| Dr KMH-IEC |
Approved |
| IEC Human care medical charitable trust |
Approved |
| Institutional Ethics Comittee-ABMH |
Approved |
| Institutional Ethics Comittee-Clinical Studies Apollo Hospitals Chennai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A90||Dengue fever [classical dengue], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexamethasone |
0.1mg IV once daily for a maximum of 5 days or until death or discharge (whichever is earlier) |
| Intervention |
Dexamethasone |
0.2mg once daily for a maximum of 5 days or until death or discharge (whichever is earlier) |
| Comparator Agent |
Usual supportive care |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Eligible participants are adult (more than18yrs) patients admitted to the hospital with dengue and meeting one of the following criteria
1. Evidence of fluid leak in the form of raised hematocrit or presence of pleural effusion or ascites (detected using bedside ultrasonography)
2. Presence of thrombocytopenia (platelet count less than 150000)
3. Any evidence of organ dysfunction in the form of altered consciousness, need for O2 supplementation or need for non-invasive or invasive ventilation, vasopressors or kidney replacement therapy
4. Evidence of liver injury (AST or ALT levels 5 times the upper limit of normal)
|
|
| ExclusionCriteria |
| Details |
1. 1.Already on long-term steroid treatment for more than 4 weeks.
2.Patients who are expected to die within the next 24 hrs.
3.Patients with the presence of an advanced directive for non-initiation of organ support
4.Duration from hospital admission more than 72hrs
5.Active tuberculosis or invasive fungal infection at the time of enrolment
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome related to feasibility consent rate adherence to protocol adverse event profiles
|
Day7
Day 28
Day 90
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Days alive and free of hospital until D90
Days alive and free or organ support until D28
Hospital and ICU length of stay
Mean change from baseline in platelets count
|
Day 4 and 7
Day 28 and 90 |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
25/11/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 will be a seamless phase 2b-3 parallel group multi-centre randomized controlled trial evaluating the effectiveness of intravenous dexamethasone for patients hospitalized with dengue and to evaluate the effectiveness of dexamethasone on days alive and free of organ support at day 28 for patients hospitalized with dengue (phase 3 objective- assumes success of pilot feasibility phas. Eligible participants are adult (>18yrs) patients admitted to the hospital with dengue (clinical diagnosis as per WHO or respective national criteria or positive for NS1 antigen or dengue polymerase chain reaction) and meeting one of the following criteria: - Evidence of fluid leak in the form of raised hematocrit or presence of pleural effusion or ascites (detected using bedside ultrasonography)
- Presence of thrombocytopenia (platelet count less than 150000)
- Any evidence of organ dysfunction in the form of altered consciousness, need for O2 supplementation or need for non-invasive or invasive ventilation, vasopressors or kidney replacement therapy
- . Evidence of liver injury (AST or ALT levels 5 times the upper limit of normal)
Primary outcomes related to feasibility (numbers enrolled/month/center), consent rate, adherence to protocol, adverse event profiles etc., Secondary outcomes: Days alive and free of hospital until D90, days alive and free or organ support until D28, day 28 and day 90 survival, hospital and ICU length of stay, mean change from baseline in platelet counts at D4 and D7 or hospital discharge whichever is earlier |