| 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
|
|
|
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
|
|
|
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
- 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).
- 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 whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- 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 [bkmeher187@yahoo.co.in].
- 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.
- 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. |