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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Pneumonia

Participation Criteria
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Eligibility Criteria
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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: 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) Radiographic findings The chest radiograph should show the presence of a new or progressive infiltration on the chest X-ray film Microbiologic criteria If sputum specimen is available and collected, both tests are mandatory with at least one of the following results is positive: (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 Patient must be able to sign a written informed consent form prior to the start of the study procedures. If any patient is unable to give consent, it must be obtained from the patient's legal representative Subject has not received more than 24 hours of a parenteral antibacterial drug for the current pneumonia. If subject has received more than 24 hours of a parenteral antibacterial drug, he/she must be declared as treatment failure. 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 Patients with abnormal pre-therapy laboratory data: aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≧ 3X ULN (upper limit of normal); or serum creatinine, urea nitrogen > 3X ULN A history of hypersensitivity to penicillins, cephalosporins, carbapenems or J-lactam/J-lactamase inhibitors Severe disease (eg. septic shock, acute respiratory distress syndrome, and multiple organ failure) which may limit survival during therapy and follow-up period, or confound the results of the study as judged by the investigator

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental Group<br> | |
| Control Group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pneumonia