Hospital-acquired pneumoniae
Conditions
Interventions
3g(q12h) group (infusion 2h):3g every 12 hours (infusion 2h)
3g(q8h) group (infusion 1.5h):3g every 8 hours (infusion 1.5h)
3g(q8h) group (infusion 2h):3g every 8 hours (infusion 2h)
3g(q6h) group (infusion 2h):3g every 6 hours (infusion 2h)
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. To provide a written informed consent sheet; 2. Male or female, aged 18 to 80 years old; 3. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (the lowest detection limit of ß-HCG is 25 IU/L); 4. Inpatients with Hospital-acquired pneumonia (HAP) including ventilator-associated pneumonia (VAP) induced by P. aeruginosa or Acinetobacter spp resistant to two or more antibiotics categories; 5. The patients who received the systematic antibacterial treatment 48 hours or less before enrollment or despite more than 48 hours, his/her infectious signs/symptoms are not improved with a positive culture of sputum or other biologic sample relative to respiratory track will be enrolled in this study. The HAP and VAP definition and diagnostic criteria are as follows: 1) HAP is defined as pneumonia either that episode only at 48 hours or more after admission, but not any evidences of pneumonia or not in incubation period at the time of admission of hospital, or that onsets within 48 hours after discharge from Hospital. VAP is specified as pneumonia that onsets after 24 hours of endotracheal intubation simultaneously with mechanical ventilation, or that emerges within 48 hours after cessation of endotracheal intubation and mechanical ventilation; 2) Chest X-ray examination displays an evidence of new radiographic infiltrate; 3) Meet at least one of the following criteria: (1) fever, oral temperature was or greater than 37.5 degree C, or rectal temperature was or greater than 38.0 degree C; (2) WBC > 10×10^9/L, or neutrophil>70%; (3) At least two or more of the following clinical features: (4) cough; (6) chest pain; (7) moist rales when perform lung auscultation; (8) purulent sputum.
Exclusion criteria
Exclusion criteria: 1. Patients with HAP concomitantly with any of the following: (1) Respiratory failure, defined as requiring 35% or more of oxygen fraction inspiration to maintain 90% or more of SaO2; (2) The chest X-ray examination showed the evidence of rapidly progressive infiltration involved multilobar or porosis formation; (3) Severe pyemia with hypotension or/and evidences of failure of organic function (shock: systolic pressure 11.0×10^9/Lor band neutrocytes = 0.5×10^9/L; (3) The radiographic infiltration was multilobar or bilateral involved; (4) systolic pressure<90mmHg; (5) diastolic pressure<60mmHg; (6) Impairment of Liver function after exclusion of any potential liver diseases and Drug-induced liver disease); 3. Patients with infection of MRSA (methicillin resistant staphylococcus aureus), Listeria, and enterococcus or any other pathogens beyond the antibacterial spectrum of Cefoperazone-sulbactam; 4. The patients with leucocytopenia (WBC<4.0×10^9/L)or neutrocytopenia (granulocyte < 2.0×10^9/L), or with treatment by glucocorticosteroid (prednisone 20mg/d, more than 2 weeks), or by immunosuppressive agent or with immunodeficiency; 5. Combination therapy that might interferer the action of cefoperazone-sulbactam, but vancomycin, norvancomycin, teicoplanin and antifungal agent are allowed; 6. Previously diagnosed condition which tend to mimic or complicate the course and evaluation of the infectious process, e.g. bronchial obstruction, obstructive pneumonia, and activate pulmonary malignant lesions which might interfere the course of the infectious disease and evaluation of the disease; 7. Liver failure, or a serious bile duct obstruction; 8. History of allergy to penicillins, cephalosporins, sulbactam and tazobactam; 9. Pregnancy or breast-feeding women; 10. Hemorrhagic tendency; 11. Any conditions investigator considered might increase the risk of patients or interfere study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentration of cefoperazone;plasma concentration of sulbactam;sputum culture;blood culture;clinical efficacy;bacteriological efficacy;comprehensive efficacy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Demographics;Vital sign;Blood routine;Blood biochemistry;Urine routine; | — |
Countries
China
Contacts
Public ContactYing-yuan Zhang
Huashan Hospital, Fudan University
Outcome results
None listed