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CTRI Number  CTRI/2024/07/071438 [Registered on: 26/07/2024] Trial Registered Prospectively
Last Modified On: 26/07/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Comparing Dexamethasone to placebo for treating severe pneumonia in children a clinical trial 
Scientific Title of Study   Dexamethasone in severe Community-Acquired Pneumonia in children: a randomised 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  Siddannagoud Salotagi 
Designation  Senior Resident 
Affiliation  AIIMS Raipur 
Address  Department of Pediatrics AIIMS Raipur 4th floor, D block, IPD Building AIIMS Raipur
Department of Pediatrics AIIMS Raipur 4th floor, D block, IPD Building AIIMS Raipur
Raipur
CHHATTISGARH
492099
India 
Phone  9740006210  
Fax    
Email  siddannagoud@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Manas Ranjan Sahoo 
Designation  Additional professor 
Affiliation  AIIMS Raipur 
Address  Department of Pediatrics AIIMS Raipur Room number 429, 4th floor, D block, IPD Building AIIMS Raipur
Department of Pediatrics AIIMS Raipur Room number 429, 4th floor, D block, IPD Building AIIMS Raipur
Raipur
CHHATTISGARH
492099
India 
Phone  7893230151  
Fax    
Email  drmrsahoo@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Siddannagoud Salotagi 
Designation  Senior Resident 
Affiliation  AIIMS Raipur 
Address  Department of Pediatrics AIIMS Raipur Room number 429, 4th floor, D block, IPD Building AIIMS Raipur
Department of Pediatrics AIIMS Raipur Room number 429, 4th floor, D block, IPD Building AIIMS Raipur
Raipur
CHHATTISGARH
492099
India 
Phone  9740006210  
Fax    
Email  siddannagoud@gmail.com  
 
Source of Monetary or Material Support  
Department of Paediatrics. IPD building 4th floor All India institute of medical science Raipur Chattisgarh India Pin code - 492010 
 
Primary Sponsor  
Name  Siddannagoud salotagi 
Address  Department of Pediatrics AIIMS Raipur Room number 429, 4th floor, D block, IPD Building AIIMS Raipur 
Type of Sponsor  Other [Self funded] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  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 Siddannagoud   AIIMS Raipur  Department of Pediatrics Pediatric Emergency and Pediatric intensive care divisions Room number 2C3 IPD Building AIIMS Raipur
Raipur
CHHATTISGARH 
9740006210

siddannagoud@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute ethics committee Aiims Raipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J17||Pneumonia in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  IV Dexamethasone  Inj Dexamethasone at 0.1mg/kg/dose 3 times a day for 5 days 
Comparator Agent  Normal saline  IV Normal saline 5ml 3 times a day for 5 days 
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  14.00 Year(s)
Gender  Both 
Details  1. Children with severe community-acquired pneumonia 
 
ExclusionCriteria 
Details  1. Child already on steroid therapy ( Any condition requiring 20 mg of prednisone equivalent/day or more for greater than 14 days over the last 3 months)
2. Known Immunodeficiency
3. Comorbidities Comorbidities: Cystic fibrosis, malignancy
4. Presence of pre-existing medical condition that is irreversible and expected to be fatal within 3 months
5. GI bleeding requiring transfusion or requiring withholding of feed for more than 24 hours
6. Active tuberculosis  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
All-cause mortality at 28 days   All-cause mortality at 28 days  
 
Secondary Outcome  
Outcome  TimePoints 
All-cause mortality at day 90
 
90 days 
New onset HAI during hospitalization  IPD days 
Duration of mechanical ventilation  Total duration of mechanical ventilation 
Duration of oxygen support  Total Duration of oxygen support 
Duration of ICU hospitalization, and hospital stay  total length of stay 
Rates of septic shock, and hyperferritinemia, by day 28   28 days 
 
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 4 
Date of First Enrollment (India)   11/08/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [siddannagoud@gmail.com].

  6. For how long will this data be available start date provided 15-07-2026 and end date provided 15-07-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

  • Pneumonia is the single greatest cause of death in children worldwide. Nearly 2 million children younger than 5 years die each year of pneumonia, representing nearly 20-24% of all deaths in children within this age group. With the widespread use of antibiotics also, there is considerable mortality among children. Increasing evidence supports a central role of the immune system in sepsis, but the current view of how sepsis affects immunity, and vice versa, is still rudimentary. Understanding how immunological alterations predispose to sepsis, key aspects of the immunopathological events during sepsis, and the long-term consequences of sepsis on a patient’s immunity are particularly important. . Cytokine storms during infections can lead to poor outcomes. It is been hypothesized that CAP patients would have different cytokine profiles according to their different causes, severity, and outcomes. Studies have shown that corticosteroids reduce proinflammatory cytokines in pneumonia and may improve clinical outcomes in adults. Hence we are conducting this study.Dexamethasone in severe Community-Acquired Pneumonia in children – a randomized controlled trial: DeCAP trial, to look for whether it reduces the mortality. In this study Patients in the intervention group will receive dexamethasone at 0.1mg/kg/dose every 8 hours for 5 days. The intravenous route will be used. Patients of the control group will receive an intravenous placebo (Normal saline) by an intravenous route at the same frequency. Dexamethasone or placebo will be given in a double-blind fashion for 5 days. Patients will be monitored any anaphylaxis reaction, features of fluid retention, Acid and electrolyte disturbances (Hypokalaemia, Hypernatremia, Metabolic alkalosis), Hyperglycaemia, Hypertension, new infections after starting dexamethasone till first 5 days. After 5 days patients will be monitored for neutrophilia, lymphopenia and new onset infections during the hospital stay or till primary outcome. In case of discharge after 5 days patient will be followed physically or telephonically to look for primary outcome and new infections. The primary and secondary outcome will be recorded and followed up for next 28 days in both the groups. Patients will also be followed till 90 days either physically or telephonically.

 
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