Intrapulmonary Penetration of Sitafloxacin and Treatment Outcomes in Thai Critically Ill Patients with Pneumonia

Not Applicable

• Conditions: VAPHAPRespiratory failure; Critically ill patients; Pneumonia; Sitafloxacin; Intrapulmonary; Pharmacokinetics

• Registration Number: TCTR20170222001
• Lead Sponsor: Ramathibodi Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-22
• Study Completion: 2018-04-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Terminated (Halted Prematurely)
• Sex: All
• Target Recruitment: 40

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified