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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  
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 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  
Status 
Not Applicable 
 
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.

 
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