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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | |||
| Control Group |
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Inclusion Criteria:
At least two of the following signs:
Cough
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)
(1) Within 24 hours prior to, or at the time of enrollment, all patients should have had a culture and susceptibility testing of respiratory secretions or sputum to study drugs (2)Gram stain of respiratory secretions or sputum
Exclusion Criteria:
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Patients with nosocomial bacterial pneumonia or healthcare-associated pneumonia(HCAP)
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| Name | Affiliation | Role |
|---|---|---|
| Wen-Sen Lee | Taipei Medical University WanFang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Medical University - WanFang Hospital | Taipei | Taiwan |
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| ID | Term |
|---|---|
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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