| 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
|
|
|
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
|
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [siddannagoud@gmail.com].
- 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.
- 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.
|