Complicated intra-abdominal Infections MedDRA version: 8.1 Level: LLT Classification code 10056570
Conditions
Interventions
Trade Name: Avalox 400 mg/250 ml Infusionslösung
Product Name: Moxifloxacin
Product Code: BAY 12-8039
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: moxifloxacin
Current Sponsor code:
Sponsors
Bayer HealthCare AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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. Documented and signed written informed consent. Consent may also be provided by a subject’s legally acceptable representative/guardian/parent (in accordance with local law). 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 and 2. The following signs and symptoms: • At least one symptom referable to the abdominal cavity (eg, nausea, vomiting, distension or pain), lasting for at least 24 hours. • At least one of the following signs: tenderness (with or without rebound), absent or diminished bowel sounds, abdominal wall rigidity • At least two of the following SIRS criteria (23): .Temperature > 38.3°C rectal or tympanic membrane, or temperature > 37.8.0°C oral or >37.3 for axillary. . Heart rate > 90/min. . Respiratory rate > 20/min. . WBC >12,000 cells/mm3 or =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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 who are pregnant or lactating or in whom pregnancy cannot be excluded (Note: a urine pregnancy test has to be performed for all women of childbearing potential before inclusion into the study). 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 hepatic insufficiency (Child Pugh C, see Appendix 10.2) or transaminase increase > 5 fold upper limit of normal (ULN). 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 prior to treatment with study medication. 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 or vascular shunt 11)Pre existing ascites and presumed spontaneous bacterial peritonitis. 12) Perforation of the stomach or duodenum, if the duration of perforation (based on first symptoms as reported by the subject) 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 (based on first symptoms as reported by the subject) is less than 12 hours. 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) Appendicitis as the source of the complicated intraabdominal infection, and therefore all types of appendicitis, with or without perforation, intaabdominal abscess or peritonitis. 20) Subjects requiring antibiotic irrigations (including prophylactic 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 µg/kg/min for noradrenaline) are accepted for any period of time as well as
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective is to compare the safety and efficacy of intravenous moxifloxacin 400 mg administered once daily with those of intravenous ertapenem 1 g once a day in adult subjects with cIAI that require surgery and parenteral antibiotic therapy 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).;Secondary Objective: Secondary efficacy parameters are: • Clinical and bacteriological response on treatment Day 5 +/- 1. • Clinical and bacteriological response at the End-of-Therapy (EOT). • Bacteriological response at the TOC visit (21 28 days after EOT). • Clinical response at the TOC visit in subjects with a bacteriologically documented intra abdominal infection. • Mortality attributable to intra abdominal infections at the time of the TOC visit (21 to 28 days after EOT). • Duration of hospitalization (total days). • Duration of hospitalization postoperatively (days). ;Primary end point(s): 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). | — |
Countries
Estonia, Germany, Greece, Latvia, Lithuania, Spain
Outcome results
None listed