Therapy of Complicated Intra-Abdominal Infections With Moxifloxacin or Ertapenem

Condition(s) targeted: Infection

Intervention: Moxifloxacin (Avelox, BAY12-8039) (Drug); Ertapenem intravenous (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

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

Official title: 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)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Number of Subjects Achieving Clinical Cure at Test of Cure (TOC) Visit in the Per Protocol Population

Secondary outcome:

Number of Subjects Achieving Clinical Improvement During Treatment in the Per Protocol Population

Number of Subjects Achieving Bacteriological Success During Treatment in the Per Protocol Population With Causative Organism(s)

Number of Subjects Achieving Clinical Cure at End of Therapy (EOT) Visit in the Per Protocol Population

Number of Subjects Achieving Bacteriological Success at EOT Visit in the Per Protocol Population With Causative Organism(s)

Number of Subjects Achieving Bacteriological Success at TOC Visit in the Per Protocol Population With Causative Organism(s)

Number of Subjects Achieving Clinical Cure at TOC Visit in the Per Protocol Population With Causative Organism(s)

Number of Subjects Who Died Due to Intra-abdominal Infections

Duration of Hospitalization

Duration of Hospitalization Postoperatively

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

- 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

Capital Federal, Argentina

Córdoba 5000, Argentina

Mendoza, Argentina

Bruxelles - Brussel 1090, Belgium

Bruxelles - Brussel 1070, Belgium

Gent 9000, Belgium

Pleven 5800, Bulgaria

Rousse 7002, Bulgaria

Sofia 1431, Bulgaria

Sofia 1606, Bulgaria

Kohtla-Jarve 30322, Estonia

Tallin EE-13419, Estonia

Tartu EE-51014, Estonia

Amilly Cedex 45207, France

Besancon 25000, France

Rio Patras 265 00, Greece

Haifa 31048, Israel

Kfar Saba 4428164, Israel

Daugavpils LV-5417, Latvia

Liepaja 3402, Latvia

Rezekne, Latvia

Riga 1002, Latvia

Riga LV-1038, Latvia

Valmiera LV-4201, Latvia

Kaunas 45130, Lithuania

Klaipeda LT-92231, Lithuania

Vilnius LT-04130, Lithuania

Vilnius 10207, Lithuania

Brasov, Romania

Bucharest 022328, Romania

Cluj-Napoca 400006, Romania

Oradea, Romania

Timisoara 300748, Romania

Moscow 119048, Russian Federation

Moscow 115280, Russian Federation

Smolensk 214019, Russian Federation

Madrid 28007, Spain

Heidelberg, Baden-Württemberg 69120, Germany

L'Hospitalet de Llobregat, Barcelona 08907, Spain

Beeskow, Brandenburg 15848, Germany

Ciudadela, Buenos Aires B1702FWM, Argentina

de Febrero 3, Buenos Aires 1657, Argentina

Florencio Varela, Buenos Aires 1888, Argentina

Merlo, Buenos Aires B1712FJN, Argentina

Cape Town, Cape 7500, South Africa

Buenos Aires, Ciudad Auton. de Buenos Aires C1180AAX, Argentina

Pretoria, Gauteng 0001, South Africa

Hannover, Niedersachsen 30625, Germany

Paderborn, Nordrhein-Westfalen 33098, Germany

Homburg, Saarland 66424, Germany

Rosario, Santa Fe, Argentina

Somerset West, Western Cape 7130, South Africa

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Starting date: July 2006
Last updated: November 3, 2014