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CTRI Number  CTRI/2025/08/093651 [Registered on: 26/08/2025] Trial Registered Prospectively
Last Modified On: 26/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of giving antibiotic into the lungs in patients with lung infection on ventilator  
Scientific Title of Study   Effect of endobronchial administration of Colistin on outcomes in patients with Ventilator Associated Pneumonia: a randomized controlled 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  Dr Arvinth V S 
Designation  Junior Resident 
Affiliation  AIIMS RISHIKESH 
Address  Department of Anaesthesiology,AIIMS Rishikesh, Veerbhadra Road

Dehradun
UTTARANCHAL
249203
India 
Phone  7010599013  
Fax    
Email  arvinthtpr@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Deepak Singla 
Designation  Additional Professor 
Affiliation  AIIMS RISHIKESH 
Address  Room No 016133 Department of Anaesthesiology,AIIMS,Virbhadra Road,Rishikesh

Dehradun
UTTARANCHAL
249204
India 
Phone  9068504999  
Fax    
Email  deepak10.4u@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Deepak Singla 
Designation  Additional Professor 
Affiliation  AIIMS RISHIKESH 
Address  Room No 016133 Department of Anaesthesiology,AIIMS,Virbhadra Road,Rishikesh

Dehradun
UTTARANCHAL
249204
India 
Phone  9068504999  
Fax    
Email  deepak10.4u@gmail.com  
 
Source of Monetary or Material Support  
All India Institute Of Medical Sciences,Rishikesh 
 
Primary Sponsor  
Name  ALL INDIA INSTITUTE OF MEDICAL SCIENCES,RISHIKESH 
Address  Veerbhadra Road,Pashulok,Rishikesh,Uttarkhand-249204 
Type of Sponsor  Research institution and hospital 
 
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 Arvinth V S  AIIMS RISHIKESH  Department of Anaesthesiology,AIIMS,Virbhadra Road,Rishikesh
Dehradun
UTTARANCHAL 
7010599013

arvinthtpr@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J15||Bacterial pneumonia, not elsewhereclassified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Endobronchial Colistin instillation and intravenous Colistin  Receive IV Colistin along with intrabronchial Colistin 
Comparator Agent  Intravenous Colistin  Receive Intravenous Colistin 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.Patients both male and female aged more than 18 years

2.Diagnosed as ventilator associated pneumonia with a CPIS score of more than 6

3.Culture positive for organisms with intermediate sensitivity to Colistin

4. Intubated on Ventilator support

 
 
ExclusionCriteria 
Details  1.Patients/next of Kin refusal to consent.

2.Patients with Multiple Organ Dysfunction Syndrome (MODS),septic shock at the beginning of the study.

3.Patients with a P/F (PaO2/FiO2) ratio below 100

4.Patients with severe COPD more than Grade GOLD 3E

5.Patients with recent myocardial infarction within 6 months or Heart failure with reduced Ejection Fraction (HFrEF) with Ejection Fraction (EF) less than 40 percentage

6.Immunodeficient patients

7.History of allergy to Colistin

8.Patients with infections resistant to Colistin
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare ventilator free days   till day 28 
 
Secondary Outcome  
Outcome  TimePoints 
CPIS score  Day 7 
CPIS score less than 6  till day 7 
To compare the mortality between the two groups  within 28 days 
To compare the length of ICU-stay between the two groups  till day 28 
To compare the length of hospital-stay between the two groups  till day 28 
adverse effects   till 3 days  
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   01/10/2025 
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  

VAP refers to pneumonia that arises more than Pneumonia has been defined as an acute infection of the pulmonary parenchyma. Pneumonia was defined by ATS/IDSA (2016) criteria clinically as the presence of “new lung infiltrate plus clinical evidence that the infiltrate is of an infectious origin, which include the new onset of fever, purulent sputum, leukocytosis, and decline in oxygenation”.Pneumonia is the eighth leading cause of death and first among infectious causes of death. The mortality rate is as high as 23% for patients admitted to the intensive care unit for severe pneumonia.

The symptoms of pneumonia include fever with chills, cough with expectoration, pleuritic chest pain, malaise, loss of appetite, myalgia. Some patients may have an altered mental status, abdominal pain and other systemic findings. Infiltrates on chest radiograph or computed tomography scan, total and differential leucocyte count, sputum gram stain, sputum culture and sensitivity and blood culture are the investigations which aids to diagnose pneumonia. Procalcitonin and C-Reactive Protein (CRP) are used to differentiate between bacterial and viral pneumonia.

Pneumonia has been classified into the following by American Thoracic Society:

1.Community Acquired Pneumonia (CAP)

2. Hospital Acquired Pneumonia (HAP)

3.Ventilator Associated Pneumonia (VAP) 

48 hours after endotracheal intubation. Ventilator-associated pneumonia (VAP) is one of the most frequent ICU-acquired infections. A data suggests that approximately 10% of patients who required mechanical ventilation were diagnosed with VAP.All-cause mortality associated with VAP ranges from 20% to 50% while attributable mortality is 13%.

The Clinical Pulmonary Infection Score (CPIS) is a tool used to assess the likelihood of ventilator-associated pneumonia (VAP) in mechanically ventilated patients. CPIS score include the following: tracheal secretions, chest x-ray infiltrates, temperature, leukocytes count, P/F ratio. CPIS score of >6 is highly suggestive of ventilator associated pneumonia in the clinical setting.  Modified CPIS score includes microbiological culture also. LUPPIS score also includes Lung Ultrasound in place of chest x-ray and Pentraxin-3 (PTX-3). ATS guidelines recommend noninvasive sampling of respiratory secretions with semi-quantitative cultures for the diagnosis of VAP.

To date there is scarcity of literature regarding the efficacy of endobronchial instillation of colistin in ventilator associated pneumonia patients. Therefore, we plan to conduct this study to evaluate the effect of endobronchial instillation of colistin on outcomes in patients with ventilator associated pneumonia


 
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