Official Title: “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 Study)”

A study to compare the safety and efficacy of moxifloxacin to ertapenem in patients with intra-abdominal infections.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Avelox (Moxifloxacin, BAY12-8039)
  • Moxifloxacin, 400mg, administered intravenously once daily
• Drug: Ertapenem intravenous
  • Active treatment: Ertapenem 1.0g, administered intravenously once daily

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Arm 1
• Active Comparator: Arm 2

Primary Measures

• The primary efficacy variable for this trial is the clinical response 21 to 28 days after the completion of study drug therapy (Test of Cure visit).
  • Time Frame: 21 to 28 days after completion of Study drug therapy
    Safety Issue?: No

Secondary Measures

• Clinical and bacteriological response on treatment Day 5 ± 1
  • Time Frame: During treatment-Day 5 + 1 Day
    Safety Issue?: No
• Clinical and bacteriological response at the End-of-Therapy (EOT)
  • Time Frame: EOT (5-14 days)
    Safety Issue?: No
• Bacteriological response at the TOC visit (21 28 days after EOT)
  • Time Frame: TOC 21-28 days after EOT
    Safety Issue?: No
• Clinical response at the TOC visit in subjects with a bacteriologically documented intra abdominal infection
  • Time Frame: TOC 21-28 days after EOT
    Safety Issue?: No
• Mortality attributable to intra abdominal infections at the time of the TOC visit (21 to 28 days after EOT)
  • Time Frame: 21-28 days after EOT
    Safety Issue?: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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 ³ 45 kg/m2
• Previous enrollment in this study
• Participation in any clinical investigational drug study within the previous 4 weeks

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Bayer

Overall Clinical Trial Officials and Contacts

Bayer Study Director Study Director Bayer  

Overall Contact: Bayer Clinical Trials Contact  clinical-trials-contact@bayerhealthcare.com

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00492726

Study ID Number: 11976

ClinicalTrials.gov Identifier: NCT00492726

Health Authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

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