| 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
|
|
|
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
|
|
|
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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