| CTRI Number |
CTRI/2024/06/068660 [Registered on: 11/06/2024] Trial Registered Prospectively |
| Last Modified On: |
07/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of nebulization of Colistin or Amikacin for prevention of ventilator-associated pneumonia in patients requiring ventilatory support in intensive care unit. |
|
Scientific Title of Study
|
Effect of prophylactic nebulization of Colistin versus Amikacin on the incidence of ventilator-associated pneumonia in an intensive care unit setting with prevalent multidrug-resistant bacteria: A prospective double-blind randomized placebo-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 |
Dr Sadik Mohammed |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Department of Anaesthesiology and Critical Care, All India Institute of Medical Sciences, Jodhpur
Jodhpur
RAJASTHAN
342008
India |
| Phone |
9466380301 |
| Fax |
|
| Email |
drmsadik@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sadik Mohammed |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Department of Anaesthesiology and Critical Care, All India Institute of Medical Sciences, Jodhpur
RAJASTHAN
342008
India |
| Phone |
9466380301 |
| Fax |
|
| Email |
drmsadik@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ankila Gupta |
| Designation |
Academic Senior Resident |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Department of Anaesthesiology and Critical Care, All India Institute of Medical Sciences, Jodhpur
Jodhpur
RAJASTHAN
342008
India |
| Phone |
9466380301 |
| Fax |
|
| Email |
ankilag@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institutional, All India Institute of Medical Sciences, Jodhpur
RAJASTHAN
342008
India |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology and Critical Care |
| Address |
All India Institute of Medical Sciences, Jodhpur
RAJASTHAN
342008
India |
| Type of Sponsor |
Government medical college |
|
|
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 Ankila Gupta |
All India Institute of Medical Sciences, Jodhpur |
Department of Anaesthesiology and Critical Care, All India Institute of Medical Sciences, Jodhpur
Jodhpur
RAJASTHAN |
9466380301
ankilag@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences, Jodhpur Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J22||Unspecified acute lower respiratory infection, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nebulization with 0.9% normal saline |
The allotted patients will receive either nebulization with 0.9% normal saline once a day for 3 days prepared by an investigator in a 5 mL syringe labeled as ‘study drug’. Disposable vibrating mesh nebulizer will be placed in the inspiratory limb of the ventilatory circuit. Duration of intervention will be three days. |
| Intervention |
Nebulization with amikacin |
The allotted patients will receive either nebulization with amikacin (amikacin at a dose of 20 mg per kilogram of ideal body weight) once a day for 3 days prepared by an investigator in a 5 mL syringe labeled as ‘study drug’. Disposable vibrating mesh nebulizer will be placed in the inspiratory limb of the ventilatory circuit. Duration of intervention will be three days. |
| Intervention |
Nebulization with colistin |
The allotted patients will receive nebulization with colistin (colistimethate sodium, 1.5M IU, diluted in water for injection) once a day for 3 days prepared by an investigator in a 5 mL syringe labeled as ‘study drug’. Disposable vibrating mesh nebulizer will be placed in the inspiratory limb of the ventilatory circuit. Duration of intervention will be three days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients requiring mechanical ventilation for more than 72 hours. |
|
| ExclusionCriteria |
| Details |
Grossly purulent sputum or pneumonia on admission; new and persistent infiltrates on chest radiography within 48 hours from admission.
Severe chronic obstructive pulmonary disease (COPD) or preexisting lung disease requiring long-term inhalation drug therapy.
Long-term therapy with corticosteroids or immunosuppressive drugs, human immunodeficiency virus infection, cancer.
Colonization or infection with a strain resistant to colistin and amikacin on admission.
Acute kidney injury on the day of inclusion. Patients undergoing renal replacement therapy or for whom a decision had been made to initiate renal replacement therapy can be included whatever the KDIGO stage.
Chronic kidney failure.
Pregnancy and breastfeeding women.
Allergy to colistin or amikacin.
Myasthenia gravis.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the incidence of VAP at Day 14 |
At Day 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the incidence of VAP at day 28.
Comparison of VAP incidence due to organisms with in vitro susceptibility to study drug.
Ventilator associated events comprising ventilator-associated conditions.
Clinical pulmonary infection score evolution after randomization.
The number of antibiotic-days (the sum of the number of systemic antibiotic treatments received each day).
Duration of mechanical ventilation from randomization to day 28.
Duration of ICU stay and hospital stay from randomization to day 28.
Evaluation of nebulization safety and side effects.
ICU-acquired infection with antibiotic-resistant bacteria, culture-confirmed urinary tract infections, blood stream infection, catheter-related blood stream infection, soft tissue infection, and intra-abdominal infection.
|
At day 28 |
|
|
Target Sample Size
|
Total Sample Size="156"
Sample Size from India="156"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| 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 - NO
|
|
Brief Summary
|
To study the effect of prophylactic nebulization of antibiotics on VAP reduction in an ICU with multidrug resistant bacteria, patients >18 years and requiring mechanical ventilation duration for >72 hours (total 156 patients), will receive either nebulization with colistin (colistimethate sodium, 1.5M IU, diluted in water for injection) or with amikacin (amikacin at a dose of 20 mg per kilogram of ideal body weight) or with an equivalent volume of 0.9% normal saline once a day for 3 days prepared by an investigator in a 5 mL syringe labeled as ‘study drug’. Disposable vibrating mesh nebulizer will be placed in the inspiratory limb of the ventilatory circuit. Complications if any will be noted. Data will be compiled and appropriate statistical test will be applied to analyse the result. The study results may be used to provide recommendation regarding the use of prophylactic antibiotics for VAP prevention particularly in the setting with prevalent multi-drug resistant bacteria. |