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CTRI Number  CTRI/2024/07/070824 [Registered on: 18/07/2024] Trial Registered Prospectively
Last Modified On: 14/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Which is better in between Nebulized Polymyxin E and Nebulized Amikacin for the prevention of ventilator-associated pneumonia 
Scientific Title of Study   Nebulized Polymyxin E and Amikacin for the prevention of ventilator-associated pneumonia-A double-blind randomized clinical study 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Harish Kumar 
Designation  Junior Resident 
Affiliation  Uttarpradesh university of medical sciences 
Address  Room num:A106 ,Swami vivekanda hostel , UPUMS,Saifai

Etawah
UTTAR PRADESH
206130
India 
Phone  9629339508  
Fax    
Email  harishthedoc@outlook.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rakesh Bahadur Singh 
Designation  Professor 
Affiliation  Uttarpradesh university of medical sciences 
Address  UPUMS, Saifai ,Etawah

Etawah
UTTAR PRADESH
206130
India 
Phone  9454152626  
Fax    
Email  harishthedoc@outlook.com  
 
Details of Contact Person
Public Query  
Name  Harish Kumar 
Designation  Junior Resident 
Affiliation  Uttarpradesh university of medical sciences 
Address  Room num:A106 ,Swami vivekanda hostel , UPUMS,Saifai

Etawah
UTTAR PRADESH
206130
India 
Phone  9629339508  
Fax    
Email  harishthedoc@outlook.com  
 
Source of Monetary or Material Support  
Uttarpradesh University of Medical Sciences,Saifai,Etawah(Dt),Uttarpradesh(State), India. Pincode-206130 
 
Primary Sponsor  
Name  Uttarpradesh University of medical sciences 
Address  Saifai , Etawah , Uttarpradesh(State). Pin-206130 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Harish Kumar  Uttarpradesh University of Medical sciences  Department of Anaesthsia, UPUMS
Etawah
UTTAR PRADESH 		 9629339508

harishthedoc@outlook.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee ,Uttar Pradesh University of Medical Sciences ,Saifai,Etawah (U.P.)-206130  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 
Comparator Agent  Nebulized Amikacin  Amikacin 20 mg/kg/day for 3 consecutive days in the nebulized form.The drugs will be given twice daily for 3 consecutive days with the help of vibrating mesh nebulizer (aerogen). 
Intervention  Nebulized Polymyxin E  Polymyxin E 5.5 mg/kg/day for 3 consecutive days in the nebulized form .The drugs will be given twice daily for 3 consecutive days with the help of vibrating mesh nebulizer (aerogen). 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients who are expected to be on mechanical ventilation for at least 72 hours. 
 
ExclusionCriteria 
Details  1. Patients who are already on mechanical ventilation for more than 96 hours.
2.Patients who are already diagnosed with or a suspected case of pneumonia
3.Patient with chronic kidney disease
4. Positive pregnancy test at the time of inclusion
5. Patient scheduled for extubation within the next 24 hours
6. Patient known to be allergic to aminoglycosides or polypeptide antibiotics at the time
of inclusion.
7. Patients who are already on systemic aminoglycoside or polypeptides antibiotics
8.Patients who are tracheostomized. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the first episode of VAP in between the two groups from randomization
to Day 28 on the basis of Clinical Pulmonary Infection Score(CPIS), 		 28 Days 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the median length of stay in days (ICU and Hospital).  28 Days 
To compare the median number of days on mechanical ventilation from
randomization to Day 28. 		 28 Days 
To compare the median number of days from randomization to first successful
spontaneous breathing trial. 		 28 Days 
Adverse reaction in between the two groups due to nebulization.  28 Days 
 
Target Sample Size   Total Sample Size="276"
Sample Size from India="276" 
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 4 
Date of First Enrollment (India)   01/08/2024 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [harishkumar.indh@gmail.com].

  6. For how long will this data be available start date provided 05-05-2026 and end date provided 05-06-2075?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
The nebulized polymyxin E vs amikacin to prevent ventilator-associated
pneumonia is an investigator-initiated, double-blind, parallel-arm, randomized, clinical
study.
After approval from institutional ethical committee, written and informed
consent will be taken from the patient’s attendant.
Total 276 patients will be included in this study and they will be divided into two
groups of 138 each by using computer generated number.
GROUP P(n=138): Polymyxin E 5.5 mg/kg/day in the nebulized form
GROUP A(n=138): Amikacin 20 mg/kg/day in the nebulized form
In both the groups, the drugs will be given twice daily for 3 consecutive days
with the help of vibrating mesh nebulizer (aerogen). Preparation of the study drugs will
be done by the nursing staff, not involved in the study.
Ventilator settings, sedation and muscle relaxants will be at the discretion of the
attending physician. However, general guidance on nebulization will be provided.
The primary outcome will be the occurrence of ventilator-associated
pneumonia. All the relevant data will be collected after start of study till 28 days or
mortality of the patient whichever occurs earlier. Patient will be monitored carefully
during the study period.
Clinical pulmonary infection score (CPIS)>6 and/or positive endotracheal
aspirate culture which will be sent every third day will be considered as patients having
ventilator-associated pneumonia .
 
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