The Role of Aerosolized Colistin in the Treatment of Ventilator-associated Pneumonia, Caused by Multidrug-resistant Gram-negative Bacteria
Phase 3
- Conditions
- Ventilator-associated Pneumonia (VAP).Bacterial pneumonia, not elsewhere classified
- Registration Number
- IRCT20151227025726N9
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 34
Inclusion Criteria
Age above 18 years
Antibiogram of positive culture that is sensitive to Colistin and resistant to all other antibiotics
The new continuous pulmonary secretions based on lung radiography among patients who are received mechanical ventilation for at least 48 hours
Fever above 38ºC without any specific reason
White Blood Cell number more than 12000 cells or less than 4000 cells in each milliliter
Purulent tracheal secretions
Exclusion Criteria
Pregnancy
Breastfeeding
Septic shock
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The correlation between antibiotic therapy initiation and the time of negative procalcitonin (PCT) test. Timepoint: Days of 0, 3, 5, 7 after antibiotic initiation. Method of measurement: Immunochromatographic test (PCT-Q).;The correlation between antibiotic therapy initiation and the time of negative sputum culture. Timepoint: Days of 0, 4, 7 after antibiotic initiation. Method of measurement: Sputum culture.
- Secondary Outcome Measures
Name Time Method Duration of ICU stay. Timepoint: Daily. Method of measurement: By the date of admission and discharge mentioned in Clinical records.;Time of fever discontinuation. Timepoint: Every other day. Method of measurement: Thermometer.;The correlation between antibiotic therapy initiation and the reduction of WBC. Timepoint: Every other day. Method of measurement: Hematologic test.;The correlation between antibiotic therapy initiation and improvement of PaO2/FiO2. Timepoint: Every other day. Method of measurement: By arterial and venous blood gasses (ABG and VBG).;Chest X-Ray changes. Timepoint: Every other day. Method of measurement: By chest x-ray radiography.;Improvement of Clinical Pulmonary Infection Score (CPIS). Timepoint: Every other day. Method of measurement: BY CPIS score.;All the adverse effects associated with the use of colistin including bronchospasm, neurotoxicity, and hypersensitivity reactions. Timepoint: Daily. Method of measurement: Clinical records.