NCT00492726已完成3 期
A Prospective, Randomized, Double-dummy, Double-blind, Multicenter Trial Comparing the Safety and Efficacy of Intravenous 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 Study)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 804
- 主要终点
- Number of Subjects Achieving Clinical Cure at Test of Cure (TOC) Visit in the Per Protocol Population
研究概览
简要总结
A study to compare the safety and efficacy of moxifloxacin to ertapenem in patients with intra-abdominal infections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized men or women >/=18 years of age
- •Expected duration of treatment with intravenous antibiotics anticipated to be >/= 5 full days but not exceeding 14 days
- •Ability to provide documented and signed written informed consent
- •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 (i.e. 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:
- •Radiological evidence [abdominal plain films, computed tomography (CT), magnetic resonance imaging (MRI) or ultrasound] of gastrointestinal perforation or intra-abdominal abscess and the following signs and symptoms:
- •Symptoms referable to the abdominal cavity (e.g. 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:
- •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
- •The subject must be scheduled for a surgical procedure (laparotomy or laparoscopy) within 24 hours of enrollment of the study
排除标准
- •Known hypersensitivity to quinolones, and/or to carbapenems and/or to any other type of beta lactam antibiotic drugs (e.g. penicillins or cephalosporins), or any of the excipients
- •Women who are pregnant or lactating or in whom pregnancy cannot be excluded
- •History of tendon disease/disorder related to quinolone treatment
- •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
- •Concomitant use of any of the following drugs, reported to increase the QT interval: antiarrhythmics class IA (e.g. quinidine, hydroquinidine, disopyramide) or antiarrhythmics class III (e.g., amiodarone, sotalol, dofetilide, ibutilide), neuroleptics (e.g. 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)
- •Known severe end stage liver disease
- •Creatinine clearance </= 30 mL/min/1.73 m2
- •Systemic antibacterial therapy administered for more than 24 hours within 7 days of enrollment
- •Need for systemic antibacterial therapy with agents other than those described in the study protocol
- •Indwelling peritoneal catheter
- •Pre existing ascites and presumed spontaneous bacterial peritonitis
- •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
- •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
- •All pancreatic processes including pancreatic sepsis, peri-pancreatic sepsis, or an intra abdominal infection secondary to pancreatitis
- •Liver and splenic abscess
- •Transmural bowel ischemia or necrosis without perforation or established peritonitis or abscess
- •Acute and gangrenous cholecystitis without perforation
- •Acute cholangitis
- •Early acute, suppurative, or gangrenous non-perforated appendicitis
- •Subjects requiring antibiotic irrigations of the abdominal cavity or surgical wound
- •Treatment with "open abdomen" or marsupialization, or multiple planned re laparotomies
- •Infections originating from the female genital tract
- •Peri-nephric infections
- •Evidence of sepsis with shock requiring the administration of vasopressors for more than 4 consecutive hours
- •Known rapidly fatal underlying disease (death expected within 6 months)
- •Neutropenia (neutrophil count < 1,000/mL) caused by immunosuppressive therapy or malignancy
- •Receiving chronic treatment with known immunosuppressant therapy (including chronic treatment with > 15 mg/day of systemic prednisone or equivalent)
- •Subjects known to have AIDS (CD4 count < 200/mL) or HIV seropositives who are receiving HAART (HIV positive subjects may be included. HIV testing is not required for this study protocol)
- •Subjects with a malignant or pre malignant hematological condition, including Hodgkin's disease and non-Hodgkin lymphoma (subjects with solid tumor can be included in the study)
- •Subjects with a Body Mass Index >/= 45 kg/m2
- •Previous enrollment in this study
- •Participation in any clinical investigational drug study within the previous 4 weeks
研究组 & 干预措施
Moxifloxacin (Avelox, BAY12-8039)
Experimental
Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
干预措施: Moxifloxacin (Avelox, BAY12-8039) (Drug)
Ertapenem
Active Comparator
Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
干预措施: Ertapenem intravenous (Drug)
结局指标
主要结局
Number of Subjects Achieving Clinical Cure at Test of Cure (TOC) Visit in the Per Protocol Population
时间窗: 21 to 28 days after completion of study drug therapy
Clinical cure at TOC = resolution or improvement of clinical signs and symptoms related to the infection without the occurrence of a wound infection requiring a systemic antibiotic treatment. Clinical failure at TOC = either failure to respond or insufficient lessening of the signs and symptoms of infection at end of treatment (EOT) or reappearance of the signs and symptoms of the original infection from EOT up to TOC or wound infection requiring additional systemic antimicrobial therapy at any time up to TOC.
次要结局
- Number of Subjects Achieving Clinical Improvement During Treatment in the Per Protocol Population(During treatment at day 5 +/- 1 day)
- Number of Subjects Achieving Bacteriological Success During Treatment in the Per Protocol Population With Causative Organism(s)(During treatment at day 5 +/- 1 day)
- Number of Subjects Achieving Clinical Cure at End of Therapy (EOT) Visit in the Per Protocol Population(after 5 - 14 days of therapy)
- Number of Subjects Achieving Clinical Cure at TOC Visit in the Per Protocol Population With Causative Organism(s)(21 - 28 days after end of therapy)
- Number of Subjects Achieving Bacteriological Success at EOT Visit in the Per Protocol Population With Causative Organism(s)(After 5 - 14 days of therapy)
- Number of Subjects Achieving Bacteriological Success at TOC Visit in the Per Protocol Population With Causative Organism(s)(21 - 28 days after end of therapy)
- Number of Subjects Who Died Due to Intra-abdominal Infections(21 - 28 days after end of treatment at TOC Visit)
- Duration of Hospitalization(From the first admission date to the discharge date (from 4 to 71 days after start of study medication))
- Duration of Hospitalization Postoperatively(Duration of hospitalization after the first surgery until discharge date (from 4 to 71 days after start of study medication))
研究者
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