| CTRI Number |
CTRI/2026/01/100110 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
31/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to assess effectiveness of Hydrocortisone in severe pneumonia patients
|
|
Scientific Title of Study
|
Efficacy and safety of Hydrocortisone in severe Pneumonia patients- A 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 Srikant Behera |
| Designation |
Assistant Professort |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Department of General Medicine All India Institute of Medical Sciences Bhubaneswar Khordha Odisha India
Khordha
ORISSA
751019
India |
| Phone |
8917219537 |
| Fax |
|
| Email |
genmed_srikant@aiimsbhubaneswar.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Srikant Behera |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Department of General Medicine All India Institute of Medical Sciences Bhubaneswar Khordha Odisha India
Khordha
ORISSA
751019
India |
| Phone |
8917219537 |
| Fax |
|
| Email |
genmed_srikant@aiimsbhubaneswar.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
DR Ashish Ranjan Sahoo |
| Designation |
Post Graduate |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Department of General Medicine All India Institute of Medical Sciences Bhubaneswar Khordha Odisha India
Khordha
ORISSA
751019
India |
| Phone |
6370170844 |
| Fax |
|
| Email |
ashishranjansahoo8@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Srikant Behera(GUIDE)AND Dr Ashish Ranjan Sahoo (STUDENT)AT- AIIMS Bhubaneswar, PS- Patrapada
DIST- Khordha , state- Odisha
country - INDIA
pin- 751019 |
|
|
Primary Sponsor
|
| Name |
DR Ashish Ranjan Sahoo and DR Srikant Behera |
| Address |
Department of General Medicine All India Institute of Medical Science Bhubaneswar Khordha Odisha |
| Type of Sponsor |
Other [self funded for PG thesis] |
|
|
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 Ashish Ranjan Sahoo |
AIIMS Bhubaneswar |
Department of General Medicine All India Institute of Medical Sciences Bhubaneswar Khordha Odisha India
Khordha
ORISSA |
6370170844
ashishranjansahoo8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituinal Ethics Commitee,All indis Institute of medical sciences Bhubaneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J189||Pneumonia, unspecified organism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hydrocortisone |
Injection Hydrocortisone 100 mg TDS for 5 days then ,100 mg BD for 3 days , 100 mg OD for 2 days given to severe Pnumonia patients |
| Comparator Agent |
standard of care |
only standard of care as per institution protocol will be followed |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
1.Diagnosis of severe pneumonia as per ATS/IDSA guideline
2.consent to participate in study
|
|
| ExclusionCriteria |
| Details |
1 Patient was already on vasopressor therapy for septic shock at the time of inclusion
2 Diagnosed case of active tb herpes infection
3 History of preexisting structural lung disease
on steroid dependent conditions
4 Hypersensitivity to corticosteroid
5 Known case of myelosuppression
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome To compare mortality of severe pneumonia patients on standard of care alone vs Hydrocortisone treatment along with standard of care at day 28
|
28 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare duration of mechanical ventilation among standard of care alone vs Hydrocortisone along with standard of care groups
|
28 day |
To compare ICU and Hospital LOS standard of care alone vs hydrocortisone along with standard of care groups
|
28 days |
To compare adverse effects of Hydrocortisone
|
10 days |
|
|
Target Sample Size
|
Total Sample Size="136"
Sample Size from India="136"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
30/01/2026 |
| 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="2"
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
|
My present study will evaluate efficacy and safety of Hydrocortisone in severe pneumonia patients in reducing mortality and duration of mechanical ventilation and hospital length of stay. Corticosteroid has strong physiological back ground for use in severe pneumonia to deal with dysregulated host response to infection There is no guideline for usage of hydrocortisone in severe pneumonia patients There is no study in indian population on Hydrocortisone treatment for severe pneumonia patients |