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CTRI Number  CTRI/2025/12/099899 [Registered on: 29/12/2025] Trial Registered Prospectively
Last Modified On: 27/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Study comparing two steroid medicines Hydrocortisone or Dexamethasone for treating patients with severe Pneumonia  
Scientific Title of Study   Comparative Efficacy and Safety of Hydrocortisone vs Dexamethasone in Severe Community Acquired Pneumonia: 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 Mahima Reddy 
Designation  Junior Resident 
Affiliation  AIIMS New Delhi 
Address  Department of Emergency Medicine All India Institute of Medical Science New Delhi Delhi 110029 India

South West
DELHI
110029
India 
Phone  8826118924  
Fax    
Email  mahimareddy2001@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rakesh Yadav 
Designation  Professor and Head of Department of Emergency Medicine 
Affiliation  AIIMS New Delhi 
Address  Department of Emergency Medicine All India Institute of Medical Science New Delhi Delhi 110029 India

South West
DELHI
110029
India 
Phone  9868026888  
Fax    
Email  rakeshyadav123@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Mahima Reddy 
Designation  Junior Resident 
Affiliation  AIIMS New Delhi 
Address  Department of Emergency Medicine All India Institute of Medical Science New Delhi Delhi 110029 India

South West
DELHI
110029
India 
Phone  6361941443  
Fax    
Email  mahimareddy2001@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Science New Delhi South West Delhi 110029 India 
 
Primary Sponsor  
Name  AIIMS New Delhi 
Address  AIIMS New Delhi Ansari Nagar, New Delhi - 110029 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mahima Reddy  AIIMS New Delhi  Department of Emergency Medicine,Internal Medicine and Pulmonary Medicine wards and ICUs in AIIMS Delhi AIIMS New Delhi Ansari Nagar, South west Delhi - 110029
New Delhi
DELHI 		 6361941443

mahimareddy2001@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE FOR BIOMEDICAL AND HEALTH RESEARCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J189||Pneumonia, unspecified organism,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  DEXAMETHASONE  In patients with Severe Community Acquired Pneumonia randomized to intervention arm Dexamethasone 7.5 mg IV would be given as Early as possible.This treatment with dexamethasone will be given for 8 days and the dose will adjusted during this duration as per the clinical response of patients. 
Comparator Agent  HYDROCORTISONE  In Patients with Severe Community Acquired Pneumonia randomized to control arm Hydrocortisone 200mg will be given as early as possible. This treatment with Hydrocortisone will be given for 8 days and the dose will be adjusted during the duration as per the clinical response of the patients. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  Patients with Severe Community Acquired Pneumonia as per Infectious Disease Society Of America Guidelines
 
 
ExclusionCriteria 
Details  1 Viral pneumonia
2 Chronic use of steroids
3 Pregnant women
4 Patients who have DNR order
5 Viral hepatitis
6 Active Herpes infection
7 Active TB
8 Fungal Pneumonia
9 Myelosupression
10 Active upper GI Bleeding
11 Diabetic Ketoacidosis
12 Hyperosmolar Hyperglycemic state
13 Hypersensitivity to steroids 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Comparing the length of Hospital stay Between Hydrocortisone vs Dexamethasone in
Patients with Severe Community Acquired Pneumonia 		 at the end of 8 days of treatment, day28 and day60 
 
Secondary Outcome  
Outcome  TimePoints 
All-Cause mortality on Day 28 and 60  day 28 and day 60 from hospital admission 
Requirement of Vasopressors and/or duration of Vasopressor
 		 duration till discharge from hospital or till death in hospital 
Requirement of Non Invasive Ventilation and/or duration of Non Invasive Ventilation  duration till discharge from hospital or till death in hospital 
Requirement of Mechanical Ventilation and/or duration of Mechanical Ventilation  duration till discharge from hospital or till death in hospital 
Side effects of steroids in terms of Hyperglycemia, Hospital Acquired Infection,
Gastro Intestinal Bleeding and dyselectrolemia  		 duration till discharge from hospital or till death in hospital 
 
Target Sample Size   Total Sample Size="126"
Sample Size from India="126" 
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)   14/01/2026 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   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 is a Prospective, Open label, Randomised Control Trial of Parallel Group to compare Efficacy and Safety of Hydrocortisone vs Dexamethasone in Patients with Severe Community Acquired Pneumonia. Patients diagnosed with Severe Community Acquired Pneumonia will be included in this study after excluding patients meeting exclusion criteria. Patients will be randomized into 2 arms using computer generated randomization sequence and allocation concealment will be done through SNOSE technique. All patients who will be recruited in the study will be explained about the study , given a patient information sheet and they will sign a consent form provided both in hindi and english.
Patients in the intervention arm will recieve Dexamethasone and those in control arm will recieve Hydrocortisone. Our primary objective is to compare the length of hospital stay between the 2 groups. Secondary objectives are to compare the all cause mortality on day 28  and day 60, the requirement and duration of requirement of vasopressors , non invasive ventilation and mechanical ventilation and to compare the adverse effects in terms of hyperglycemia ,hospital acquired infections ,Gastro intestinal  bleeding and dyselectrolytemia.

 
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