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

Conditions: Complicated intra-abdominal Infections
MedDRA version: 8.1Level: LLTClassification code 10056570

Registration Number: EUCTR2006-000874-56-LT

Lead Sponsor: Bayer HealthCare AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 845

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 < 4,000 cells/ mm3.
and
3. The subject must be scheduled for a surgical procedure (laparotomy or
laparoscopy) within 24 hours of enrollment in 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

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 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