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Efficacy of intravenous immunoglobulin in improving mortality in children with severe adenoviral pneumonia.

Efficacy of Intravenous Immunoglobulin versus Placebo in Combination with Standard Care for Children with Severe Adenoviral Pneumonia: A Randomised, Double-Blind, Multicenter Trial - IIMPACT trial

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/12/098705
Enrollment
170
Registered
2025-12-09
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J120- Adenoviral pneumonia

Interventions

Intervention1: 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 wit

Sponsors

ICMR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children (1mo-14 years) with severe pneumonia admitted to the pediatric ICU and HDU with RT-PCR positive for adenovirus.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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.Timepoint: 0, 2weeks and 4 weeks

Secondary

MeasureTime frame
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.Timepoint: o, 2 weeks, 4 weeks

Countries

India

Contacts

Public ContactBijay Kumar Meher

SVPPGIP, SCB Medical College, Cuttack

bkmeher187@yahoo.co.in9437089714

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026