To compare the effect of inhaled amikacin and placebo in ventilated pediatric patients for reduction of ventilator associated pneumonia. A randomized controlled trial.

To study the outcome of inhaled amikacin vs placebo in ventilated pediatric. A randomised control trial. - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/06/088347

Enrollment

Registered

2025-06-05

Start date

Unknown

Completion date

Unknown

Last updated

2025-06-24

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

Conditions

Health Condition 1: J180- Bronchopneumonia, unspecified organism

Interventions

Intervention1: Nebulization with amikacin on once day basis for three days.: Test group will receive nebulization with adjunctive amikacin at 20 mg/kg on once a day basis for three days. Control Inter

Eligibility

Inclusion criteria

Inclusion criteria: Pediatric patients from new born to 18 years children undergoing mechanical ventilation.

Exclusion criteria

Exclusion criteria: Pediatric patients from new born to 18 years undergoing mechanical ventilation but having deranged renal function and those not willing to provide consent.

Design outcomes

Primary

Measure	Time frame
Incidence of ventilator associated pneumonia in both the groups as per modified Clinical Pulmonary Infection Score.Timepoint: From Day 3 to Day 14 of intubation.	—

Secondary

Measure	Time frame
Comparison of PICU and hospital mortality rates between two groupsTimepoint: From day 3 to day 14 of intubation.;Duration of mechanical ventilationTimepoint: ;Incidence of adverse events related to amikacin in test group.Timepoint: upto day 14 of intubation or at extubation, whichever is earlier.;antibiotic resistance pattern in isolated pathogen.Timepoint: ;Incidence of acute kidney injury in both the groups.Timepoint: by day 14 of intubation or at extubation, whichever is earlier	—

Measure

Time frame

Comparison of PICU and hospital mortality rates between two groupsTimepoint: From day 3 to day 14 of intubation.;Duration of mechanical ventilationTimepoint: ;Incidence of adverse events related to amikacin in test group.Timepoint: upto day 14 of intubation or at extubation, whichever is earlier.;antibiotic resistance pattern in isolated pathogen.Timepoint: ;Incidence of acute kidney injury in both the groups.Timepoint: by day 14 of intubation or at extubation, whichever is earlier

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Countries

India

Contacts

Public ContactUnnati Prajapati

All India Institute of Medical Sciences, Jodhpur

drkirtirathod@gmail.com08769429995

Outcome results

None listed

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