CTRI Number |
CTRI/2025/05/087651 [Registered on: 26/05/2025] Trial Registered Prospectively |
Last Modified On: |
20/05/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Prevention of Lung Infections in Ventilated Patients: A Study Comparing Digestive Tract decontamination by antibiotic formulation versus Standard of Care |
Scientific Title of Study
|
Selective Digestive Decontamination versus Standard of Care in Prevention of ventilator Associated Pneumonia: A Randomized 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 |
Nishit Kumar Sahoo |
Designation |
Senior Resident |
Affiliation |
PGIMER, Chandigarh |
Address |
room no- 1, F block, level- 4, Department of Internal Medicine Nehru Hospital, PGIMER, Chandigarh
Chandigarh CHANDIGARH 160012 India |
Phone |
09439288777 |
Fax |
|
Email |
kanha.nishit@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Navneet Sharma |
Designation |
Professor |
Affiliation |
PGIMER, Chandigarh |
Address |
Room No- 25, Department of Internal Medicine, F block, level- 4, Nehru Hospital, PGIMER, Chandigarh
Chandigarh CHANDIGARH 160012 India |
Phone |
7087009537 |
Fax |
|
Email |
sharma.navneet@pgimer.edu.in |
|
Details of Contact Person Public Query
|
Name |
Nishit Kumar Sahoo |
Designation |
Senior Resident |
Affiliation |
PGIMER, Chandigarh |
Address |
room no- 1, F block, level- 4, Department of Internal Medicine Nehru Hospital, PGIMER, Chandigarh
Chandigarh CHANDIGARH 160012 India |
Phone |
09439288777 |
Fax |
|
Email |
kanha.nishit@gmail.com |
|
Source of Monetary or Material Support
|
Post Graduate Institute of Medical Education & Research Chandigarh |
|
Primary Sponsor
|
Name |
NONE |
Address |
NONE |
Type of Sponsor |
Other [NONE] |
|
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 Nishit Kumar Sahoo |
PGIMER |
Division of Acute care & Emergency Medicine
Department of Internal Medicine
PGIMER
Chandigarh Chandigarh CHANDIGARH |
9439288777
kanha.nishit@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee (intramural) PGIMER, Chandigarh |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Selective digestive decontamination |
non absorbable gastrointestinal suspension and paste of colistin, tobramycin and nystatin
Topical Application (Oropharyngeal):
- 0.5g oral paste containing:
- 10mg colistin
- 10mg tobramycin
- 1,25,000 IU Nystatin
- Applied to the buccal mucosa and oropharynx every 6 hourly
Gastric Administration (Upper Gastrointestinal Tract):
- 10mL gastric suspension containing:
- 100mg colistin
- 80mg tobramycin
- 20,00,000 IU Nystatin
- Administered every 6 hourly via a nasogastric or orogastric tube
|
Comparator Agent |
Standard of care |
chlorhexidine mouth wash 6hourly
chlorhexidine body wash 6hourly |
|
Inclusion Criteria
|
Age From |
12.00 Year(s) |
Age To |
85.00 Year(s) |
Gender |
Both |
Details |
Critically ill patients requiring mechanical ventilation
Expected to require mechanical ventilation for at least 48 hours (APACHE IV)
Admitted to the intensive care unit (ICU)
Informed consent from patients or their legal representatives
|
|
ExclusionCriteria |
Details |
Age less than 12 years
Intubated or mechanically ventilated 48 hours before presentation to the study setting.
Pneumonia at the time of presentation
Patients with known allergies to study medications
Pregnant or breastfeeding women
Patients with a history of selective digestive decontamination
Active tuberculosis
Known immunocompromised status
inability to enroll within 4 hours of endotracheal intubation
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Primary Outcome:
Occurrence of Ventilator associated pneumonia in both the groups during index hospital admission
|
every 48 hourly till the patient is extubated or develops ventilator associated pneumonia |
|
Secondary Outcome
|
Outcome |
TimePoints |
Secondary outcomes:
Duration of endotracheal intubation
All cause mortality within 28 days of hospital admission
Development of antimicrobial resistance
length of hospital stay |
every 48 hourly |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
31/05/2025 |
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="0" 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
|
Ventilator-associated pneumonia (VAP) remains one of the most common
nosocomial infections in the intensive care unit (ICU) affecting one-third of
patients that require mechanical ventilation during a noninfectious admission.(1) The estimated incidence
varies (depending on definition, screening methods, and patient populations)
from 2 to 30 episodes per 1000 days of mechanical ventilation, and the disease
develops in 5 to 40% of intubated, critically ill patients.(1-4) whereas mortality shoots
up to 20-42% of the VAP patients. the
American Thoracic Society and Infectious Diseases Society of America jointly published
practical guidelines on hospital-acquired infection, and VAP was defined as a
new pneumonia in patients with mechanical ventilation for at least 48 hours and
characterized by the presence of a new or progressive infiltrate, signs of
systemic infection (temperature, blood cell count), changes in sputum
characteristics, and detection of the causative agent(5).
Several measures have been
documented for prevention of ventilator associated pneumonia such as avoiding
intubation, minimize duration of intubation, and preventing reintubations,
minimal sedation, subglottic suction (6) but still it has been a
major concern for the health care fraternity. The potential source of
ventilator associated pneumonia has been attributed to be the gut and
pharyngeal colonization by harmful gram negative organisms, which enter the
respiratory tract and the blood stream. SDD targets those organisms from gut
with topical antibiotics without getting absorbed from the gut lumen so that
they don’t get into blood stream and don’t affect the protective anaerobic
flora especially pseudomonas, Enterobacteriaceae group. (7)
Selective digestive decontamination is another modality of preventing the
colonization of gram-negative aerobic bacteria and thereby preventing
ventilator associated pneumonia.(8) Though selective
digestive decontamination concept has been incorporated since 1982, (9) but till now extensive use
in intensive care setting is rare. Also there has not been any studies
done in Indian population as per our knowledge and the literature available.
This study aims to study the incidence of ventilator associated pneumonia in
patients receiving SDD and to compare that with patients receiving standard of
care in an Indian setting. |