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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
TCTR
Registry ID
TCTR20170222001
Enrollment
40
Registered
2017-02-22
Start date
2017-03-15
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

VAP HAP Respiratory failure Sitafloxacin Intrapulmonary Critically ill patients Pneumonia Pharmacokinetics

Interventions

ATB which desired by primary doctors ,given sitafloxacin for combination

Sponsors

Ramathibodi Hospital
Lead Sponsor
Faculty of Pharmacy&#44
Collaborator
Mahidol University
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

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

MeasureTime 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

MeasureTime frame
mortality rate 28 days mortality rate,ventilator free day 28 day with ventilator

Countries

thailand

Contacts

Public Contactjaipak Kaemapairoj

investigator

jai-pak@hotmail.com(66)22011629

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026