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

Selective Digestive Decontamination versus Standard of Care in Prevention of ventilator Associated Pneumonia: A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/05/087651
Enrollment
60
Registered
2025-05-26
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: R00-R99- Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified

Interventions

Intervention1: Selective digestive decontamination: non absorbable gastrointestinal suspension and paste of colistin, tobramycin and nystatin Topical Application (Oropharyngeal): - 0.5g oral past

Sponsors

NONE
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Primary Outcome: Occurrence of Ventilator associated pneumonia in both the groups during index hospital admission Timepoint: every 48 hourly till the patient is extubated or develops ventilator associated pneumonia

Secondary

MeasureTime frame
Secondary outcomes: Duration of endotracheal intubation All cause mortality within 28 days of hospital admission Development of antimicrobial resistance length of hospital stayTimepoint: every 48 hourly

Countries

India

Contacts

Public ContactNishit Kumar Sahoo

PGIMER, Chandigarh

sharma.navneet@pgimer.edu.in7087009537

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026