Comparison of intravenous colistin plus nebulized colistin against intravenous ampicillin-sulbactam plus nebulized colistin in treating ventilator associated pneumonia caused by Acinetobacter baumannii
- Conditions
- Ventilator-Associated Pneumonia due to Acinetobacter baumannii.Pneumonia due to other aerobic Gram-negative bacteria
- Registration Number
- IRCT20120703010178N18
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 28
Participant with endotracheal intubation days > 48 hours
Pneumonia diagnosis as clinical features (which include the new onset of fever (T > 38), purulent sputum, leukocytosis or leukopenia (WBC > 11000 cells/mm3 or < 4000 cells/mm3), biologic (microorganism concentration in sputum >?10?^5 CFU/ml) and radiographic evidences (new lung infiltrates)
Sputum culture of Acinetobacter baumannii
History of hypersensitivity reactions to beta-lactam antibiotics or colistin
Have received effective antibiotics for this episode of ventilator associated pneumonia for more than 72 hours before study medication administration
Patients on dialysis
Immunodeficiency (HIV with CD4 < 200 cells/mm3, ANC < 500/mm3? leukemia, lymphoma, chemotherapy within the last 3 weeks)
Sever Acute respiratory distress syndrome (PaO2/Fio2 < 100)
Endobronchial obstruction such as stenosis or mass in the endobronchial
Sever bronchospasm
Lung abscess
Empyema
Chest trauma
Co-infection in another organs
Comorbidities: cystic fibrosis? myasthenia or atelectasis
Pregnancy and lactation
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Microbiological evaluation. Timepoint: Before intervention and 4, 7 , 10 days after intervention. Method of measurement: Negative sputum culture for Acinetobacter.
- Secondary Outcome Measures
Name Time Method Clinical signs evaluation. Timepoint: 4, 7 , 10 days after intervention. Method of measurement: Removing clinical and improving radiological manifestations - Successful weaning from ventilator between days 5 to 14 - Negative sputum culture for acinetocanter.;Side effects evaluation. Timepoint: Daily and until antibiotics are given. Method of measurement: Laboratory measurements Cr.;Procalcitonin level evaluation. Timepoint: before intervention and 4, 7 , 10 days after intervention. Method of measurement: Laboratory scaling.