| CTRI Number |
CTRI/2024/11/076717 [Registered on: 12/11/2024] Trial Registered Prospectively |
| Last Modified On: |
12/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to determine whether administering an inhaled antibiotic can prevent pneumonia in children who are on a ventilator |
|
Scientific Title of Study
|
Nebulized amikacin versus placebo for the prevention of ventilator associated pneumonia: A double-blind randomised controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arjun Kurup |
| Designation |
DM Resident (Pediatric Pulmonology and Intensive Care) |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Pediatrics,
All India Institute of Medical Sciences,
New Delhi
South West
DELHI
110029
India |
| Phone |
9497763452 |
| Fax |
|
| Email |
arjunkurup89@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jhuma Sankar |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Division of Pediatric Pulmonology and Intensive Care,
Department of Pediatrics,
All India Institute of Medical Sciences,
New Delhi
South West
DELHI
110029
India |
| Phone |
9818399864 |
| Fax |
|
| Email |
jhumasankar@aiims.edu |
|
Details of Contact Person
Public Query
|
| Name |
Arjun Kurup |
| Designation |
DM Resident (Pediatric Pulmonology and Intensive Care) |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Pediatrics,
All India Institute of Medical Sciences,
New Delhi
DELHI
110029
India |
| Phone |
9497763452 |
| Fax |
|
| Email |
arjunkurup89@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New Delhi - 29 |
|
|
Primary Sponsor
|
| Name |
Department of Pediatrics |
| Address |
All India Institute of Medical Sciences,
Sri Aurobindo Marg,
Ansari Nagar,
Ansari Nagar East,
New Delhi, Delhi - 110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Bahamas |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Arjun Kurup |
PICU AIIMS |
Department of Pediatrics,
All India Institute of Medical Sciences
South West
DELHI |
9497763452
arjunkurup89@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, All India Institute of Medical Sciences, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J958||Other intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Amikacin nebulization |
Dose: 20 mg/kg/dose (0.2 mL/kg/dose);
Route: Inhalation (Nebulization);
Frequency: Once daily;
Total duration: 3 days |
| Comparator Agent |
Placebo nebulisation |
Dose : 0.2 mL/kg/dose of Normal saline;
Route: Inhalation (Nebulization);
Frequency: Once daily;
Total duration: 3 days |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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. |
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 Outcome
|
| Outcome |
TimePoints |
| 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 PICU |
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 Mortality |
28 days |
|
|
Target Sample Size
|
Total Sample Size="184"
Sample Size from India="184"
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 3 |
|
Date of First Enrollment (India)
|
23/11/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Ventilator associated pneumonia (VAP) is one of the
most common health-care associated infections in the world, and is associated
with significant mortality and morbidity. The present management of VAP
predominantly involved incorporation of care bundles for its prevention. There
exists literature based on studies in adults which propose that prophylactic
administration of of inhaled antibiotics, especially Aminoglycosides, may
have a beneficial role in the prevention of VAP. However, no randomised
controlled trials have been conducted to assess the efficacy of Inhaled
Aminoglycosides in the prevention of VAP in children.
The study aims to enrol 184 ventilated children in 2
arms (Amikacin nebulization and Placebo nebulization, 92 patients in each arm) from
the time of approval till July 2026 and nebulize them with the allotted
intervention for a period of 3 days.
The primary objective of the study will be to
determine the incidence of VAP in children in the 2 arms, with secondary
objectives including PICU length of stay, mortality, emergence of drug resistant
strains (on BAL cultures), incidence of ventilator-associated events (VAE) and various
other parameters.
|