PER-001-98已完成未知
A Prospective, Multicenter, Double-blind, Randomized Comparative Study to Evaluate the Safety, Tolerability, and Efficacy of MK-0826 Versus Piperacillin-Tazobactam in the Treatment of Complicated Intra-abdominal Infections in Hospitalized Adults
MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 0 人开始时间: 1998年1月1日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
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
- •-Intraoperative/Postoperative Enrollment: patients may be enrolled intraoperatively or postoperatively upon visual confirmation (presence of pus within the abdominal cavity) of an intraabdominal infection. Surgical intervention includes open laparotomy, percutaneous drainage of an abscess, or laparoscopic surgery. Diagnoses considered eligible for this study are those in which there is evidence of intraperitoneal infection. These include the following: 1) Cholecystitis with gangrene rupture or progression of the infection beyond the gallbladder wall; 2) Diverticular abscess; 3) Appendiceal perforation and peri-appendiceal abscess; 4) Acute gastric and duodenal perforations, only if operated on >24 hours after perforation occurs; 5) Traumatic perforation of the intestines, only if operated on >12 hours after perforation occurs; 6) Secondary peritonitis (but not spontaneous bacterial peritonitis associated with cirrhosis and chronic ascites); 7) Intra-abdominal abscess (including of liver and spleen).
- •-For Preoperative Enrollment: the following clinical criteria must be met, and the patient´s infection must be confirmed by a surgical intervention within 24 hours of entry: 1) Evidence of a systemic inflammatory response (temp >100.0° F oral, >100.4°F tympanic, >100.8°F rectal; WBC>10,500/mm3; systolic blood pressure >90mmHg; increased pulse and respiratory rates; hypoxemia; altered mental status), 2) Physical findings consistent with intra-abdominal infection (abdominal pain and/or tenderness, localized or diffuse abdominal wall rigidity, mass, ileus), 3) Supportive radiologic findings in abdomen such as intraperitoneal abscess detected on CT scan films, and 4) The requirement for surgical intervention, including open laparotomy, percutaneous drainage of an abscess, or laparoscopic surgery.
- •-Specimens from the surgical intervention are sent for culture and susceptibility testing.
- •-Infection is caused or presumed to be caused by microorganisms susceptible to the intravenous study antibiotics (MK-0826 and piperacillin/tazobactam).
- •-The patient is an adult (male or female) >18 years of age.
- •-Females of childbearing potential must have a negative serum pregnancy test (b-HCG) prior to enrollment into the study and, subsequently, for at least 1 month of study treatment use adequate birth control measures as discussed with the investigator. Hormonal contraceptives should not be used as the sole method of birth control, because of the effect of MK-0826.
排除标准
- •-Failure to meet all inclusion criteria.
- •-Diagnosis of traumatic bowel perforation with surgery within 12 hours; perforation of gastroduodenal ulcers with surgery within 24 hours (these are considered situations of peritoneal soiling before infection has become established). Other intra-abdominal processes in which the primary etiology is not likely to be infectious.
- •-Simple cholecystitis; simple appendicitis; acute suppurative cholangitis; infected, necrotizing pancreatitis.
- •-Patients to be managed by Staged Abdominal Repair (STAR).
- •-Patients known at study entry to have intra-abdominal infections that are caused by pathogens resistant to the study antimicrobial agents
- •-History of serious allergy, hypersensitivity (e.g., anaphylaxis), or any serious reaction to carbapenem antibiotics (such as imipenem), piperacillin/tazobactam, any penicillins or other b-lactam agents. Patients with history of mild rash to penicillins or other b-lactams may be enrolled.
- •-APACHE n score >30.
- •-Patients who are considered unlikely to survive the 6- to 8-week study period.
- •-Patients in whom a response to antibiotic therapy is considered unlikely.
- •-Pregnant women, nursing women, or fertile women not practicing adequate methods of contraception; women planning to become pregnant within 1 month of the study.
- •-Administration of systemic antimicrobial agents within the 72-hour period prior to study entry, unless either of the following pertains: 1) Treatment with non-study systemic antibiotic consisted of postoperative (or post-drainage) therapy of no more than one dose of an appropriate antimicrobial regimen for patients not considered to have failed a previous regimen; 2) Patient is considered to have failed the previous treatment regimen (the treatment is thought to have been inadequate, there are operative findings of infection, operative intervention is intended no more than 24 hours after study entry, specimens for bacterial cultures and susceptibility testing are taken at operative intervention, no further non-study antibiotics are administered postoperatively prior to initiation of study therapy)
- •-The need for concomitant systemic antimicrobials (other than vancomycin or antifungal agents) in addition to those designated in the two study groups (for use of vancomycin, and antifungal therapy.
- •-Concurrent infection that would interfere with evaluation of response to the study antibiotic.
- •-Presence of renal or hepatic disease:
- •1) Serum creatinine >2.0 x the upper limit of the range of normal (ULN) values used by the laboratory performing the test for patients <65 years of age, and >1.5 x ULN used by the laboratory performing the test for patients >65 years of age.
- •2) Liver function tests (ALT, AST) >6 x ULN values used by the laboratory performing the test. Patients with elevations of AST and/or ALT up to 10 X ULN will be allowed if these elevations are acute and directly related to the infectious process being treated.
- •3) Patients with acute hepatic failure or acute decompensation of chronic hepatic failure should be excluded.
- •-Hematocrit <25% or hemoglobin <8 g/dL.
- •-Neutropenia with absolute neutrophil count (ANC) <1000/mm3. Patients with neutrophil counts as low as 500 cells/mm3 will be permitted if this reduction is due to the acute infectious process.
- •-Platelet count <75,000/mm3. Patients with platelet counts as low as 50,000 cells/mm3 will be permitted i
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