| CTRI Number |
CTRI/2025/02/080372 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
10/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Evaluation of efficacy of inhaled Amikacin in prevention of Ventilator Associated Pneumonia in children aged one month to 18 years |
|
Scientific Title of Study
|
Evaluation of efficacy of inhaled Amikacin in prevention of Ventilator Associated Pneumonia in children aged one month to 18 years: An open Labelled 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 |
Neethu Ravi |
| Designation |
Junior Resident |
| Affiliation |
AIIMS, Rishikesh |
| Address |
Department of Pediatrics, Shivaji Nagar,Veerbhadra Road, AIIMS Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
7892929564 |
| Fax |
|
| Email |
neethuravi145@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Lokesh Tiwari |
| Designation |
Professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Pediatrics, Shivaji Nagar, Veerbhadra Road, AIIMS Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9631638095 |
| Fax |
|
| Email |
lokeshdoc@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Lokesh Tiwari |
| Designation |
Professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Pediatrics, Shivaji Nagar, Veerbhadra Road, AIIMS Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9631638095 |
| Fax |
|
| Email |
lokeshdoc@yahoo.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Rishikesh, Shivaji Nagar, Veerbhadra road, Rishikesh, Uttaranchal
Pincode: 249203 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical sciences, Rishikesh |
| Address |
Shivaji Nagar, Veerbhadra Road, AIIMS Rishikesh, 249203 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Neethu Ravi |
AIIMS Rishikesh |
235, Pediatric Intensive Care Unit, 3rd Floor, Shivaji Nagar, Veerbhadra Road, Rishikesh
Dehradun
UTTARANCHAL |
7892929564
neethuravi145@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, AIIMS RISHIKESH |
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 |
Inhaled amikacin alonf with standard care |
Inhaled amikacin 20 mg/kg/day once a day for 5 days along with standard care for prevention of Ventilator associated Pneumonia |
| Comparator Agent |
Standard care |
Standard care which includes 1)Oral hygiene: Colonization of the oral cavity leads to further colonization of the tracheal tube and the lungs by the bacteria, which will create easy passage to the lung tissue; therefore, regular oral rinsing or cleaning with chlorhexidine mouthwash (0.12%) for decontamination, reduction of plaque formation thus preventing gingivitis and use of toothbrush and oral swabs to remove dental plaque/debris in daily oral care is recommended.
2)Preventive measures to reduce iatrogenic spread of infection: strict adherence to hand hygiene practices and universal precautions
3)Measures to prevent aspiration of gastric contents: proper patient positioning by elevating the head end between 30-45 degrees and lateral positioning. Use low-volume, low-pressure cuffs in ETT and avoid gastric over-distension.
4)ETT secretion clearance: use inline suction equipment where appropriate and available; suction the hypopharynx before endotracheal suctioning and repositioning; change the circuits when visible, soiled, or malfunctioning; and always use a humidifier or heat moisture exchanger.
5)Shorten the duration of ventilation:Spontaneous breathing trails and sedation window with neuromuscular blockade holidays. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Mechanically ventilated children between the ages of one month - 18 years of age admitted to PICU, Department of Paediatrics, AIIMS Rishikesh |
|
| ExclusionCriteria |
| Details |
1. Already on invasive mechanical ventilation for more than 24 hours
2. Children who received invasive mechanical ventilation within the previous seven days
3. Severe acute kidney injury without renal replacement therapy, chronic kidney disease
4.Children scheduled for extubation within the next 24 hours
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of VAP after the five-day course of inhaled Amikacin |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•Duration of mechanical ventilation, PICU stay, and antibiotic therapy in days
•Proportion of children getting successful extubation
•All-cause mortality at discharge or day 28 (whichever is earlier)
•Occurrence of adverse events (bronchospasm, acute kidney injury, and amikacin-resistant VAP |
Discharge or day 28 of hospital stay |
|
|
Target Sample Size
|
Total Sample Size="348"
Sample Size from India="348"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
All mechanically ventilated children aged 1 months to 18 years old admitted to PICU will be enrolled after randomization and informed consent as per inclusion and exclusion criteria. In intervention arm inhaled amikacin will be given at 20 mg/kg once a day for days along with standard care for prevention of ventilator assocaited pneumonia. In comparator arm only standard care for prevention of ventilator assocaited pneumonia will be given. All enrolled children will be assessed daily for development of ventilator associated pneumina as per CDC and MCPIS score daily till day 7 of enrolment. For secondary outcome child will be followed till discharge or day 28 which ever is earlier. |