Prevention of Lung Infections in Ventilated Patients: A Study Comparing Digestive Tract decontamination by antibiotic formulation versus Standard of Care

Not yet recruiting

Conditions: Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified,

Registration Number: CTRI/2025/05/087651

Brief Summary: Ventilator-associated pneumonia (VAP) remains one of the most commonnosocomial infections in the intensive care unit (ICU) affecting one-third ofpatients that require mechanical ventilation during a noninfectious admission.(1) The estimated incidencevaries (depending on definition, screening methods, and patient populations)from 2 to 30 episodes per 1000 days of mechanical ventilation, and the diseasedevelops in 5 to 40% of intubated, critically ill patients.(1-4) whereas mortality shootsup to 20-42% of the VAP patients. theAmerican Thoracic Society and Infectious Diseases Society of America jointly publishedpractical guidelines on hospital-acquired infection, and VAP was defined as anew pneumonia in patients with mechanical ventilation for at least 48 hours andcharacterized by the presence of a new or progressive infiltrate, signs ofsystemic infection (temperature, blood cell count), changes in sputumcharacteristics, and detection of the causative agent(5).

Several measures have beendocumented for prevention of ventilator associated pneumonia such as avoidingintubation, minimize duration of intubation, and preventing reintubations,minimal sedation, subglottic suction (6) but still it has been amajor concern for the health care fraternity. The potential source ofventilator associated pneumonia has been attributed to be the gut andpharyngeal colonization by harmful gram negative organisms, which enter therespiratory tract and the blood stream. SDD targets those organisms from gutwith topical antibiotics without getting absorbed from the gut lumen so thatthey don’t get into blood stream and don’t affect the protective anaerobicflora especially pseudomonas, Enterobacteriaceae group. (7)

Selective digestive decontamination is another modality of preventing thecolonization of gram-negative aerobic bacteria and thereby preventingventilator associated pneumonia.(8) Though selectivedigestive 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 studiesdone in Indian population as per our knowledge and the literature available.This study aims to study the incidence of ventilator associated pneumonia inpatients receiving SDD and to compare that with patients receiving standard ofcare in an Indian setting.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Outcome:	every 48 hourly till the patient is extubated or develops ventilator associated pneumonia
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 Measures

Name	Time	Method
Secondary outcomes:	Duration of endotracheal intubation

Trial Locations

Locations (1): PGIMER
🇮🇳
Chandigarh, CHANDIGARH, India
PGIMER
🇮🇳Chandigarh, CHANDIGARH, India
Dr Nishit Kumar Sahoo
Principal investigator
9439288777
kanha.nishit@gmail.com