An Open-label, Randomized, and Comparative Study to Evaluate the Efficacy and Safety of Cefoperazone/Sulbactam in Comparison to Cefepime for the Treatment of Hospital-acquired Pneumonia and Healthcare-associated Pneumonia

Taipei Medical University WanFang Hospital1 site in 1 country142 target enrollmentJuly 2010

ConditionsPneumonia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Pneumonia
Sponsor: Taipei Medical University WanFang Hospital
Enrollment: 142
Locations: 1
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a phase III, multi-center, open-label, comparative and randomized study in evaluating the efficacy and safety of cefoperazone/sulbactam versus cefepime for the treatment of hospital-acquired pneumonia and healthcare-associated pneumonia. The investigator will determine the total duration of study therapy, as clinically indicated. The minimum duration of study therapy will be 7 days and the maximum allowable duration of study therapy will be 21 days.

Detailed Description

Patients fulfill inclusion/exclusion criteria will be randomly assigned (in a 1:1 ratio)to receive intravenous cefoperazone/sulbactam or intravenous cefepime for 7\~21days. Vitamin K1 10mg will be administered to cefoperazone/sulbactam group every 24 hours. The assessment of clinical sign and symptoms of pneumonia and microbiological tests will be performed at early post-therapy visit and test-of-cure visit.

Registry

clinicaltrials.gov

Start Date

July 2010

End Date

December 2011

Last Updated

15 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Taipei Medical University WanFang Hospital

Eligibility Criteria

Inclusion Criteria

•Male or female patients aged ≧18 years old
•Patients with nosocomial bacterial pneumonia at least 48 hours after hospitalization or patients with healthcare-associated pneumonia(HCAP\*).
•Clinical findings
•At least two of the following signs:
•Fever: axillary temperature \> 37.5℃ or tympanic temperature \> 38.5℃
•Hypothermia: axillary temperature \< 34℃ or tympanic temperature \< 35℃
•Purulent sputum production or respiratory secretion
•Total peripheral white blood cell (WBC) count \> 10,000/mm3; or \> 15% band forms, regardless of total peripheral white count; or leucopenia with total WBC \< 4500/mm3
•Auscultatory findings on pulmonary examination of rales and/or evidence of pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony)
•Hypoxemia (defined as a partial O2 pressure \<60 mmHg while the patient was breathing normal air or a decrease in the partial O2 pressure of ≧25% from an initial value)

Exclusion Criteria

•Woman who are pregnant (determined by urine test) or lactating state
•Patients with known bronchial obstruction or a history of postobstructive pneumonia. (This does not exclude patients who have chronic obstructive pulmonary disease)
•A neutrophil count \<1000/mm3
•Patients with pneumonia due to viral, fungal, or mycobacterial infection.
•Patients who were known to have been infected with human immunodeficiency virus
•Documented Legionella pneumonia
•Patients were infected with gram negative (G-) microorganism known to be resistant to one of the study antibiotics during trial
•Subjects with sputum gram stain of PMN\>25, epithelial cell \<10, and gram positive (G+) cocci in cluster predominant and phagocytosis
•Patients who have received any other investigational drug within 30 days prior to enrollment
•Patients who have received medications like cefoperazone, cefoperazone/sulbactam and cefepime within 30 days prior to enrollment