EUCTR2006-000874-56-DE进行中（未招募）不适用
A prospective, randomized, double dummy, double blind, multi-center trial comparing the safety and efficacy of moxifloxacin 400 mg IV QD 24 hours to that of ertapenem 1.0 g IV QD 24 hours for 5 to 14 days for the treatment of subjects with complicated intra-abdominal infections. - PROMISE
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 845
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects must meet all the following inclusion criteria:
- •1.Hospitalized men or women ? 18 years of age.
- •2.Expected duration of treatment with intravenous antibiotics anticipated to be ? 5 full days but not exceeding 14 days.
- •3.Ability to provide documented and signed written informed consent.
- •4.Confirmed or suspected intra abdominal infection defined as follows:
- •. For a confirmed intra abdominal infection, a surgical procedure (laparotomy or laparoscopy) must have been performed within 24 hours prior to enrollment and reveal at least one of the following:
- •Gross peritoneal inflammation with purulent exudates (ie, peritonitis).
- •Intra abdominal abscess.
- •Macroscopic intestinal perforation with localized or diffuse peritonitis.
- •. Subjects enrolled on the basis of a suspected intra abdominal infection must have:
- •1.Radiological evidence [abdominal plain films, computed tomography (CT), magnetic resonance imaging (MRI) or ultrasound] of gastrointestinal perforation or intra-abdominal abscess
- •2.The following signs and symptoms:
- •Symptoms referable to the abdominal cavity (eg, anorexia, nausea, vomiting or pain), lasting for at least 24 hours.
- •Tenderness (with or without rebound), involuntary guarding, absent or diminished bowel sounds, or abdominal wall rigidity.
- •At least two of the following SIRS criteria (23):
- •. Temperature > 38.0°C rectal or tympanic membrane, or temperature < 36.0°C rectal or tympanic.
- •. Heart rate > 90/min.
- •. Respiratory rate > 20/min.
- •. WBC >12,000 cells/mm3 or < 4,000 cells/ mm3.
- •3.The subject must be scheduled for a surgical procedure (laparotomy or laparoscopy) within 24 hours of enrollment of the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1)Known hypersensitivity to quinolones, and/or to carbapenems and/or to any other type of beta lactam antibiotic drugs (eg, penicillins or cephalosporins), or any of the excipients.
- •2)Women of childbearing potential in whom the possibility of pregnancy cannot be excluded by a negative serum pregnancy test at Pre-treatment (Day 0).
- •Women of childbearing potential who are not using a reliable method of contraception. Methods of contraception that are considered reliable are hormone containing intrauterine devices (IUDs), birth control pills, hormonal implants/patches, and barrier contraception when used with spermicidal products.
- •3)History of tendon disease/disorder related to quinolone treatment.
- •4)Known congenital or documented acquired QT prolongation; uncorrected hypokalemia; clinically relevant bradycardia; Clinically relevant heart failure with reduced left-ventricular ejection fraction; previous history of symptomatic arrhythmias.
- •5)Concomitant use of any of the following drugs, reported to increase the QT interval: antiarrhythmics class IA (eg, quinidine, hydroquinidine, disopyramide) or antiarrhythmics class III (eg, amiodarone, sotalol, dofetilide, ibutilide), neuroleptics (eg, phenothiazines, pimozide, sertindole, haloperidol, sultopride), tricyclic antidepressive agents, certain antimicrobials (sparfloxacin, erythromycin IV, pentamidine, antimalarials, particularly halofantrine), certain antihistaminics (terfenadine, astemizole, mizolastine), and others (cisapride, vincamine IV, bepridil, diphemanil).
- •6)Known severe end stage liver disease (Child Pugh C, see Appendix 10.2).
- •7)Creatinine clearance ? 30 mL/min/1.73 m2 (the Cockroft-Gault formula for calculating creatinine clearance is given in Appendix 10.5).
- •8)Systemic antibacterial therapy administered for more than 24 hours within 7 days of enrollment.
- •9)Need for systemic antibacterial therapy with agents other than those described in the study protocol (Note: prophylactic anti-fungal therapy is accepted).
- •10)Indwelling peritoneal catheter.
- •11)Pre existing ascites and presumed spontaneous bacterial peritonitis.
- •12)Perforation of the stomach or duodenum, if the duration of perforation is less than 24 hours or if operated on within 24 hours of perforation.
- •13)perforation of the small bowel (excluding the duodenum) or large bowel, if the duration of perforation is less than 12 hours or if operated on within 12 hours of perforation.
- •14)All pancreatic processes including pancreatic sepsis, peri-pancreatic sepsis, or an intra abdominal infection secondary to pancreatitis.
- •15)Liver and splenic abscess.
- •16)Transmural bowel ischemia or necrosis without perforation or established peritonitis or abscess.
- •17)Acute and gangrenous cholecystitis without perforation.
- •18)Acute cholangitis.
- •19)Early acute, suppurative, or gangrenous non-perforated appendicitis.
- •20)Subjects requiring antibiotic irrigations of the abdominal cavity or surgical wound.
- •21)Treatment with open abdomen or marsupialization, or multiple planned re laparotomies.
- •22)Infections originating from the female genital tract.
- •23)Peri-nephric infections.
- •24)Evidence of sepsis with shock requiring the administration of moderately high or high doses of vasopressors for more than 12 consecutive hours. Low doses of vasopressors (eg., < 5 µg/kg/min for dopamine or < 0.2 mg/kg/min for noradrenaline) are accepted for any period of time as well as moderately high or high doses of vasopressors for less than 12
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