Pneumonia
Conditions
Keywords
Pneumonia
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.
Interventions
None listed
Sponsors
Taipei Medical University WanFang Hospital
Study design
Observational model
COHORT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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: 1. Cough 2. Fever: axillary temperature \> 37.5℃ or tympanic temperature \> 38.5℃ 3. Hypothermia: axillary temperature \< 34℃ or tympanic temperature \< 35℃ 4. Purulent sputum production or respiratory secretion 5. 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 6. Auscultatory findings on pulmonary examination of rales and/or evidence of pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony) 7. 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
Countries
Taiwan
Outcome results
None listed