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CTRI Number  CTRI/2025/12/098705 [Registered on: 09/12/2025] Trial Registered Prospectively
Last Modified On: 05/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Efficacy of intravenous immunoglobulin in improving mortality in children with severe adenoviral pneumonia.  
Scientific Title of Study   Efficacy of Intravenous Immunoglobulin versus Placebo in Combination with Standard Care for Children with Severe Adenoviral Pneumonia: A Randomised, Double-Blind, Multicenter Trial 
Trial Acronym  IIMPACT trial 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bijay Kumar Meher 
Designation  Professor Pediatrics 
Affiliation  SVPPGIP, SCB Medical College, Cuttack 
Address  Department of Pediatrics, SVPPGIP, SCB Medical College, Cuttack

Cuttack
ORISSA
753002
India 
Phone  9437089714  
Fax    
Email  bkmeher187@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Bijay Kumar Meher 
Designation  Professor Pediatrics 
Affiliation  SVPPGIP, SCB Medical College, Cuttack 
Address  Department of Pediatrics, SVPPGIP, SCB Medical College, Cuttack

Cuttack
ORISSA
753002
India 
Phone  9437089714  
Fax    
Email  bkmeher187@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Bijay Kumar Meher 
Designation  Professor Pediatrics 
Affiliation  SVPPGIP, SCB Medical College, Cuttack 
Address  Department of Pediatrics, SVPPGIP, SCB Medical College, Cuttack

Cuttack
ORISSA
753002
India 
Phone  9437089714  
Fax    
Email  bkmeher187@yahoo.co.in  
 
Source of Monetary or Material Support  
Indian Council of Medical Research, Ansari Nagar, New Delhi, India 
 
Primary Sponsor  
Name  ICMR 
Address  ICMR, New Delhi 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Debasmita Rath  IMS and SUM Hospital  Department of Pediatrics, Kalinga Nagar, Bhubaneswar
Khordha
ORISSA 
9437253854

debasmita1976.dr@gmail.com 
DR BIJAY KUMAR MEHER  SVPPGIP, SCB Medical College, Cuttack  Room No 520, G+6, Department of Pediatrics,
Cuttack
ORISSA 
9437089714

bkmeher187@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee, IMS and SUM Hospital  Submittted/Under Review 
Institutional Ethics Committee, S.C.B. Medical College & Hospital, Cuttack  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J120||Adenoviral pneumonia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intravenous Immunoglobulin in Combination with Standard Care   Children with severe adenoviral pneumonia will be randomly assigned to receive IVIG (2g/kg over 2 days) in combination with standard care  
Comparator Agent  Standard Care   Children with severe adenoviral pneumonia will be randomly assigned to receive standard care alone 
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  14.00 Year(s)
Gender  Both 
Details  Children (1mo-14 years) with severe pneumonia admitted to the pediatric ICU and HDU with RT-PCR positive for adenovirus. 
 
ExclusionCriteria 
Details  1. Patients presenting with proven bacterial pneumonia, empyema or hospital-acquired pneumonia.
2. Patients for whom the use of IVIG is contraindicated.
3. Patients who developed secondary HLH after adenoviral infection.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Clinical improvement within 28 days after randomization. Clinical improvement is defined as a two-point reduction after the use of the drug in patients clinical status on a six-point ordinal scale or live discharge from the hospital, whichever comes first.   0, 2weeks and 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcomes include all-cause mortality at day 28, frequency of invasive mechanical ventilation, duration of oxygen support, duration of hospitalization, & need for organ support.  o, 2 weeks, 4 weeks 
 
Target Sample Size   Total Sample Size="170"
Sample Size from India="170" 
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)   01/02/2026 
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="3"
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  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 whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  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 [bkmeher187@yahoo.co.in].

  6. For how long will this data be available start date provided 01-08-2029 and end date provided 31-07-2032?
    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  

Rationale/Gaps in Existing Knowledge: Viral pneumonia is a critical issue in children in the PICU. Adenovirus causes up to 10% of global respiratory infections in children, with high mortality in infants and immunocompromised patients. IVIG may help due to its immunomodulatory effects, but no formal guidelines or trials exist for its use in adenoviral pneumonia.

Novelty: IVIG in severe adenoviral pneumonia could reduce morbidity and mortality with minimal toxicity.

Objectives: Compare morbidity and mortality in children with adenoviral pneumonia receiving IVIG versus those not receiving IVIG.

Methods: Children with suspected viral pneumonia needing respiratory support will receive oxygen, ventilators, drugs, fluids, and antibiotics. Nasopharyngeal swabs or aspirates will be collected from non-ventilated children, and mini-BAL samples from those with invasive ventilation. These will be tested for adenovirus using the BIOFIRE panels. Participants will be randomly assigned to receive either IVIG (2g/kg over 2 days) or a placebo. The primary endpoint is the time to clinical improvement up to day 28, defined by a reduction of two levels on a six-point ordinal scale or discharge alive. Secondary outcomes include mortality, ventilator support, vasopressor therapy, hospitalization duration, organ dysfunction, and other complications. Primary analysis will use an intention-to-treat basis, and safety analysis will include all who started treatment. This trial will be registered with ClinicalTrials.gov.

Expected Outcomes: Differences in the outcome between the two groups will provide useful information for the use and recommendation of intravenous immunoglobulin in severe adenoviral pneumonia in children.

 
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