VAP HAP Respiratory failure Sitafloxacin Intrapulmonary Critically ill patients Pneumonia Pharmacokinetics
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. aged more than 18 years who compatible with HAP/VAP 2. respiratory failure which required mechanical ventilator to maintain oxygen saturation more than 90% 3. hemodynamic stable, BP > 90/60 4. new or progress of infiltration in chest radiology 5. suspected pneumonia caused by A. baumannii, P. aeruginosa, and Extended Spectrum β-Lactamase (ESBL)-Gram negative pathogens, and/or received at least one antibiotics for empirical treatment of hospital-acquired infections.
Exclusion criteria
Exclusion criteria: 1. patients or their authorities refuse to participate in this study 2. patients who pregnant 3. patients who lived with HIVS 4. patients who have history with fluoroquinolone allergy 5. patients who has contraindication to receive sitafloxacin 6. patients who has contraindication to BAL 7. patients who have QT prolongation (> 480 ms) 8. patients who have history of recent unstable angina or myocardial infraction, increase ICP 9. patients who have bleeding tendency eg. platelet less than 80,000, INR more than 1.3
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome of treatment of HAP/VAP with sitafloxacin 72 hours decrease CPIS scores,Sitafloxacin penetration 12 hours Sitafloxacin concentrations in plasma and epithelial lining fluid | — |
Secondary
| Measure | Time frame |
|---|---|
| mortality rate 28 days mortality rate,ventilator free day 28 day with ventilator | — |
Countries
thailand
Contacts
investigator