Investigating phage therapy in the prevention of ventilator-induced bacterial pneumonia in patients admitted to the pediatric intensive care unit
Phase 3
- Conditions
- Ventilator-associated Bacterial Pneumonia.Bacterial pneumonia, not elsewhere classified
- Registration Number
- IRCT20230701058628N1
- Lead Sponsor
- Mazandaran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Age <18 years
The reason for the need for mechanical ventilation is not bacterial pneumonia
need for mechanical ventilation for more than 2 days
Exclusion Criteria
Need ventilator <48 hours
Neonates < 28 days
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Positive endotracheal culture. Timepoint: Once every three days from the time of drug nebulization. Method of measurement: Culture by mini-BAL (Mini bronchoalveolar lavage) method.;Occurance of Ventilator-associated pneumonia. Timepoint: Daily. Method of measurement: Fever above 38°C without any other cause or white blood cell below 4000 or leukocytosis = 12000 white cells per cubic millimeter and at least two cases of new purulent sputum onset, change in sputum characteristics, increased respiratory secretions or increased need for suction, onset or worsening of cough, shortness of breath or tachypnea; rales or bronchial lung sounds; Worsening of blood gases (for example, increased need for oxygen or increased ventilator settings).
- Secondary Outcome Measures
Name Time Method Death. Timepoint: Which day of hospitalization. Method of measurement: The time of death of the patient based on medical record.;Discharge from PICU or hospital. Timepoint: One week after extubation. Method of measurement: Discharge from PICU or hospital based on medical record.