A prospective, multicenter, double-blind, randomized, comparative study to estimate the safety, tolerability and efficacy of NXL104/ceftazidime plus metronidazole vs. meropenem in the treatment of complicated intra-abdominal infections (cIAI) in hospitalized adults.

ovexel SA0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

阶段: 2 期
状态: 已完成
发起方

研究概览入排标准研究者记录与标识符相似试验

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

•1. For 18 to 65 years of age
•Women are authorized to participate in this clinical study if they meet the following criteria:
• Has been surgically sterilized or post menopausal for at least one year
• Is of childbearing potential, and all of the following conditions are met:
•-had normal menstrual periods for the 3 months prior to study entry, and
•-has a negative serum pregnancy test (serum -hCG) within 1 day prior to enrollment.
•-must be willing to practice double barrier methods of birth control (e.g., condoms or diaphragms together with spermicidal foam or gel) during treatment and for at least 28 days after dosing with study medication. Oral contraceptives should not be used as the sole method of birth control, because the effect of NXL104 on the efficacy of oral contraceptives has not yet been established.
•2. For Intraoperative/postoperative enrollment
•Patients may be enrolled intraoperatively or postoperatively upon visual confirmation (presence of pus within the abdominal cavity) of an intra-abdominal 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. The patient must have one of the following diagnoses:
•a. cholecystitis with gangrenous rupture or perforation or progression of the infection beyond the gallbladder wall
•b. diverticular disease with perforation or abscess
•c. appendiceal perforation or peri-appendiceal abscess
•d. acute gastric and duodenal perforations, only if operated on > 24 hours after perforation occurs
•e. traumatic perforation of the intestines, only if operated on > 12 hours after perforation occurs
•f. secondary peritonitis (but not spontaneous bacterial peritonitis associated with cirrhosis and chronic ascites)
•g. intra-abdominal abscess (including of liver and spleen)
•Specimens from the surgical intervention are sent for culture and susceptibility testing
•Infection is caused or presumed to be caused by mircroorganisms susceptible to the intravenous study medications (ceftazidime/NXL104 plus metronidazole or meropenem)
•Note: 1) infections limited to the hollow viscus, such as simple cholecystitis and simple appendicitis, are not eligible. Ischemic bowel disease without perforation is not eligible. Acute suppurative cholangitis and acute necrotizing pancreatitis are not eligible. 2) Postoperative (or intraoperative) enrollment of patients is encouraged. If, however, preoperative data are available that strongly suggest an appropriate diagnosis for entry (e.g., rupture of intraperitoneal abscess on CT or MRI), then these patients may be enrolled preoperatively.
•3. 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:
•a. Evidence of systemic inflammatory response, with at least one of the following:
•1)Fever (temperature > 37.8°C; > 38°C tympanic; > 38.3°C rectal; or hypothermia with a core body temperature < 35°C
•2)Elevated WBC (> 10,500/mm3)
•3)Drop in blood pressure (however, systolic BP must be > 90 mm Hg without pressor support)
•4)Increased pulse (HR > 90) and respiratory rates (> 20)
•5)Hypoxemia
•6)Altered mental status
•b.Physical findings consistent with Intra-abdominal infection, such as:
•1)Abdominal pai

排除标准

•1. Patient diagnosed with traumatic bowel perforation with surgery within 12 hours; perforation of gastroduodenal ulcers with surgery within 24 hours. Other intra-abdominal processes in which the primary etiology is not likely to be infectious.
•2. Patient with abdominal wall abscess or small bowel obstruction without perforation or ischemic bowel without perforation.
•3. Patient with simple cholecystitis; or gangrenous cholecystitis without rupture; or simple appendicitis; or acute suppurative cholangitis; or infected necrotizing pancreatitis or pancreatic abscess
•4. Patient whose surgery will include staged abdominal repair, or ?open abdomen? technique, or marsupialization.
•5. Patient known at study entry to have intra-abdominal infections that are caused by pathogens resistant to the study antimicrobial agents.
•6. Patient with evidence of sepsis with shock not responding to intravenous fluid challenge or anticipated to require the administration of vasopressors for > 12 hours.
•7. Patient with perinephric infections.
•8. Female patient with infection of the genital tract.
•9. Patient with indwelling peritoneal catheter.
•10.Patient with history of serious allergy, hypersensitivity (e.g., anaphylaxis), or any serious reaction to carbapenem or cephalosporin antibiotics or other beta lactam antibiotics.
•11.Patient with APACHE II score > 25 (see appendix 6).
•12.Patient who is considered unlikely to survive the 6- to 8-week study period.
•13.Patient who is unlikely to respond to 5 to 14 days of antibiotic therapy.
•14.Patient with rapidly progressive or terminal illness, including acute hepatic failure or respiratory failure.
•15.Male patient who is not willing to abstain from sexual intercourse with a fertile woman without use of a condom/spermicide while taking the study drug and for at least 90 days after treatment with study drug.
•16.Female patient who is pregnant or breastfeeding, or fertile woman not practicing adequate methods of contraception (as defined in inclusion criteria); or planning to become pregnant within 1 month of the study.
•17.Patient who received systemic antibacterial agents within the 72-hour period prior to study entry, unless either of the following pertains:
•?Patient treated with nonstudy systemic antibiotic consisting of postoperative (or postdrainage) therapy of no more than 24 hours of an appropriate antimicrobial regimen for patients not considered to have failed a previous regimen;
•?Patient is considered to have failed the previous treatment regimen. In this case, preoperative treatment of any duration with nonstudy systemic antimicrobial therapy for peritonitis or abscess is permitted provided that;
•a) the treatment regimen has been administered for at least 72 hours and is thought to have been inadequate
•b) findings of infection were documented at surgery
•c) operative intervention is intended no more than 24 hours after study entry
•d) specimens for bacterial cultures and susceptibility testing are taken at operative intervention
•e) no further nonstudy antibacterials are administered after enrollment
•18.Patient who needs effective concomitant systemic antibacterials (other than vancomycin for documented Methicillin Resistant S. aureus or Enteroccal infections) in addition to those designated in the 2 study groups.
•19.Patient with concurrent infection that may interfere with the evaluation of response to the study antibiotic.
•20.Patient with a BMI > 45 kg/m2.
•21.Patient with Hematocrit <30% or Hemogl

研究者

发起方

ovexel SA

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