PER-032-99已完成未知
A Multicenter Comparative Study of Cefepime Versus Broad-Spectrum Antibacterial Therapy in Moderate and Severe Bacterial Infections
试验速览
- 阶段
- 未知
- 状态
- 已完成
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Age 18 years or older;
- •The subject or their legally authorized representative who has given their informed consent to participate in the study.
- •All women with the potential to conceive should have a documented pregnancy test in serum or urine, with a negative result and a minimum sensitivity of 25 IU / 1 human chorionic gonadotropin (BHCG), obtained within 48 hours prior to start of study drug administration (see Appendix I); Women with potential to conceive (MCPC) are those who have experienced menarche and have not undergone surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or are not in postmenopause [defined as amenorrhea for 12 consecutive months or more ; women who are receiving hormone replacement therapy (TSH) with a documented plasma level of follicle-stimulating hormone (FSH)> 35 mlUl / ml]. Women who are using oral contraceptive, implant or injectable hormones or mechanical products such as intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy; who practice abstinence or whose partner is sterile (for example, vasectomy) will be considered as women with potential to conceive.
- •Patients requiring hospitalization or patients who have been hospitalized for less than 3 days;
- •Patients with a score of> 5 and <19 in the APACHE II classification system
- •The diagnosis of pneumonia requires clinical evidence of pneumonia verified by the presence of a new infiltrate or infiltrates on the chest radiograph and two or more of the following characteristics:
- •-fever (> 38 ° C or I00.4 ^ F)
- •-leukocytosis (> 10,000 leukocytes / mm ^ or> 15% in bands)
- •purulent sputum (> 25 PMN and <10 squamous epithelial cells per low power field)
- •- chest pain
- •- abnormal auscultatory findings, such as rales or egophony
- •- headache
- •- general discomfort
- •Infection of the urinary tract
- •The diagnosis of urinary tract infection requires the isolation of> 10 leukocytes / hpf obtained from centrifuged urine collected by the sterile collection technique or by catheterization, and two of the following conditions:
- •-Fever (> 38.0 ° C or 100.4 ° F);
- •-Leukocytosis (> 10,000 leukocytes / mm ^ or> 15% in bands);
- •- Symptoms of the upper tract (pain in the side or back or abnormal sensitivity of the costovertebral angle).
- •The history of recurrent urinary tract infections and known urological complications (such as kidney stones, obstruction, neurogenic bladder, prostatic hypertrophy) should be recorded in the case report form.
- •Clinical evidence of sepsis verified by;
- •Fever (> 38.0 ° C or 100.4 ° F) or hypothermia (<36.0 ° C);
- •Tachycardia> 90 Ipm;
- •Leukocytosis (> 12,000 leukocytes / nim ^ o> 10% band forms) or leukopenia (<4,000 leukocytes / mm ^);
- •Respiratory frequency> 20;
- •PAC02 <32 mmHg
- •Evidence or suspicion of infection elsewhere, and at least one of the following characteristics:
- •- Hypotension (reduction of systolic and diastolic pressures by 20 mmHg
- •and 10 mmHg, respectively, below the baseline value of the patient for at least 8 hours in the absence of another evident cause in addition to sepsis);
- •- Oliguria (<15 ml / hr of urine for 4 hours);
- •-Hyperventilation (respiratory rate> 25 Ipm, or an increase of 15 Ipm, above the baseline value of the patient during 4 hours, in
排除标准
- •Pregnancy and / or lactation;
- •Patients with scores of <5 or> 19 in the Apache II classification system
- •A life expectancy of less than 3 days or patients who have been placed in a no resuscitate state;
- •History of type I reaction or anaphylactic reaction to penicillins and
- •/ or to any of the study drugs (Cephalosporins of 1, 2, 3 or 4 ^ generation, aminoglycosides, macrolides, metronidazole and vancomycin).
- •Current, clinically significant liver disease (ie, ALT and / or
- •AST and / or total bilirubin> 5 times the normal maximum limit);
- •Chronic renal failure (such as, for example, patients with a serum creatinine level> 3.0 mg / dl or who require renal dialysis);
- •Patients requiring intubation for respiratory support (except for patients who require intubation for the administration of surgical anesthesia);
- •Any other condition or therapy that, in the opinion of the Investigator or as indicated on the product label, could entail a risk to the patient or interfere with the objectives of the study;
- •Administration of any other investigational medication within 30 days prior to the start of treatment, and participation in other clinical studies at the same time as in this protocol;
- •Any other condition for which, in the opinion of the investigator, the patient is not eligible to be admitted to the study.
研究者
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