A study to determine whether administering an inhaled antibiotic can prevent pneumonia in children who are on a ventilator

Nebulized amikacin versus placebo for the prevention of ventilator associated pneumonia: A double-blind randomised controlled trial - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/11/076717

Enrollment

184

Registered

2024-11-12

Start date

Unknown

Completion date

Unknown

Last updated

2024-12-09

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

Conditions

Health Condition 1: J958- Other intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified

Interventions

Intervention1: Amikacin nebulization: Dose: 20 mg/kg/dose (0.2 mL/kg/dose)

Route: Inhalation (Nebulization)

Frequency: Once daily

Total duration: 3 days Control Intervention1: Placebo nebulisation: Dose : 0.2 mL/kg/dose of Normal saline

Total duration: 3 days

Eligibility

Inclusion criteria

Inclusion criteria: All children between the age of 1 month to 15 years admitted in the PICU with a duration of mechanical ventilation of not more than 96 hours.

Exclusion criteria

Exclusion criteria: Patients with contraindications to the disconnection of the ventilator circuit due to the underlying disease process. Microbiologically confirmed VAP on the day of inclusion. Patient scheduled for extubation in the next 24 hours. Patient ventilated through an endotracheal tube for more than 4 consecutive days before inclusion (96 hours). Patients ventilated through tracheostomy. Patients allergic to aminoglycosides.

Design outcomes

Primary

Measure	Time frame
To study the effect of prophylactic nebulization with Amikacin on the ventilator associated pneumonia rate in mechanically ventilated children 1 month to 15 years of age admitted to the PICU till day-28 post randomisation.Timepoint: To study the effect of prophylactic nebulization with Amikacin on the ventilator associated pneumonia rate in mechanically ventilated children 1 month to 15 years of age admitted to the PICU till day-28 post randomisation.	—

Measure

Time frame

To study the effect of prophylactic nebulization with Amikacin on the ventilator associated pneumonia rate in mechanically ventilated children 1 month to 15 years of age admitted to the PICU till day-28 post randomisation.Timepoint: To study the effect of prophylactic nebulization with Amikacin on the ventilator associated pneumonia rate in mechanically ventilated children 1 month to 15 years of age admitted to the PICU till day-28 post randomisation.

—

Secondary

Measure	Time frame
To study the effect of prophylactic nebulization with Amikacin in mechanically ventilated children between 1 month to 15 years of age admitted to the PICU on length of stay in the PICUTimepoint: 28 days;To study the effect of prophylactic nebulization with Amikacin in mechanically ventilated children between 1 month to 15 years of age admitted to the PICU on MortalityTimepoint: 28 days	—

Countries

Bahamas

Contacts

Public ContactArjun Kurup

All India Institute of Medical Sciences, New Delhi

jhumasankar@aiims.edu9818399864

Outcome results

None listed

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