Trial Condition(s):

Infection

Therapy of Complicated Intra-Abdominal Infections with Moxifloxacin or Ertapenem

Bayer Identifier:

11976

ClinicalTrials.gov Identifier:

NCT00492726

EudraCT Number:

2006-000874-56

Study Completed

Trial Purpose

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

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 >/= 45 kg/m2
 - Previous enrollment in this study
 - Participation in any clinical investigational drug study within the previous 4 weeks

Trial Summary

Enrollment Goal
804
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Avelox (Moxifloxacin hydrochloride, BAY12-8039)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Kreiskrankenhaus Beeskow

Beeskow, Germany, 15848

Status
Completed
 
Locations

Universitätsklinikum des Saarlandes

Homburg, Germany, 66424

Status
Completed
 
Locations

Centre Hospitalier Montargoise - Amilly Cedex

AMILLY CEDEX, France, 45207

Status
Completed
 
Locations

Hopital J. Minjoz - Besançon

BESANCON, France, 25000

Status
Completed
 
Locations

Ciutat Sanitària i Universitària de Bellvitge

L'Hospitalet de Llobregat, Spain, 08907

Status
Completed
 
Locations

Hospital General Universitario Gregorio Marañón

Madrid, Spain, 28007

Status
Completed
 
Locations

UZ Gent

GENT, Belgium, 9000

Status
Completed
 
Locations

Hôpital Erasme/Erasmus Ziekenhuis

BRUXELLES - BRUSSEL, Belgium, 1070

Status
Completed
 
Locations

UZ Brussel

BRUXELLES - BRUSSEL, Belgium, 1090

Status
Completed
 
Locations

Vergelegen Medi-Clinic

Somerset West, South Africa, 7130

Status
Completed
 
Locations

Pretoria Academic Hospital Ethics Committee

Pretoria, South Africa, 0001

Status
Completed
 
Locations

University of Stellenbosch

CAPE TOWN, South Africa, 7500

Status
Completed
 
Locations

MHAT Ruse AD

Rousse, Bulgaria, 7002

Status
Completed
 
Locations

UMHAT Dr. Georgi Stranski

Pleven, Bulgaria, 5800

Status
Completed
 
Locations

Hospital de Agudos "Dr. Carlos Bocalandro"

de Febrero 3, Argentina, 1657

Status
Completed
 
Locations

Universitätsklinikum Heidelberg

Heidelberg, Germany, 69120

Status
Completed
 
Locations

Brüderkrankenhaus St. Josef

Paderborn, Germany, 33098

Status
Completed
 
Locations

Kliniken der Medizinischen Hochschule Hannover

Hannover, Germany, 30625

Status
Completed
 
Locations

Meir Medical Center

Kfar Saba, Israel, 4428164

Status
Completed
 
Locations

Bnai Zion Medical Center

Haifa, Israel, 31048

Status
Completed
 
Locations

Military Medical Academy

Sofia, Bulgaria, 1431

Status
Completed
 
Locations

Multiprofile Hospital for Active Treatment and Emergency Med

Sofia, Bulgaria, 1606

Status
Completed
 
Locations

Hosp. Municipal de Agudos "Mi Pueblo"

Florencio Varela, Argentina, 1888

Status
Completed
 
Locations

Sanatorio Güemes

Buenos Aires, Argentina, C1180AAX

Status
Completed
 
Locations

Hospital Zonal General de Agudos 'Heroes de Malvinas'

Merlo, Argentina, B1712FJN

Status
Completed
 
Locations

Hospital Zonal General de Agudo 'Dr. Ramón Carrillo

Ciudadela, Argentina, B1702FWM

Status
Completed
 
Locations

Nuevo Hospital San Roque

Córdoba, Argentina, 5000

Status
Completed
 
Locations

Hospital de Emergencias Clemente Alvarez

Rosario, Argentina

Status
Completed
 
Locations

Smolensk Medical Academy

Smolensk, Russia, 214019

Status
Completed
 
Locations

Sanatorio San José

Capital Federal, Argentina

Status
Completed
 
Locations

Hospital Central

Mendoza, Argentina

Status
Completed
 
Locations

University General Hospital of Patras

Rio Patras, Greece, 265 00

Status
Completed
 
Locations

City Clinical Hospital no 13

Moscow, Russia, 115280

Status
Completed
 
Locations

1st Medical Academy Municipal Hospital N61

Moscow, Russia, 119048

Status
Completed
 
Locations

University Hospital of Vilnus City

Vilnius, Lithuania, 10207

Status
Completed
 
Locations

Klaipeda District Hospital

Klaipeda, Lithuania, LT-92231

Status
Completed
 
Locations

Regional Hospital of North Estonia

Tallin, Estonia, EE-13419

Status
Completed
 
Locations

Rezekne Hospital

Rezekne, Latvia

Status
Completed
 
Locations

Fundeni Clinical Institute

Bucharest, Romania, 022328

Status
Completed
 
Locations

County Clinical Hospital

Oradea, Romania

Status
Completed
 
Locations

Kaunas District Hospital

Kaunas, Lithuania, 45130

Status
Completed
 
Locations

Vilnius University Hospital of Emergency Care

Vilnius, Lithuania, LT-04130

Status
Completed
 
Locations

Tartu University Clinics

Tartu, Estonia, EE-51014

Status
Completed
 
Locations

Ida-Viru Central Hospital

Kohtla-Jarve, Estonia, 30322

Status
Completed
 
Locations

Paula Stradina Kliniskas Universitates slimnica

Riga, Latvia, 1002

Status
Completed
 
Locations

Valmiera Hospital

Valmiera, Latvia, LV-4201

Status
Completed
 
Locations

Riga Clinical Hospital "Gailezers"

Riga, Latvia, LV-1038

Status
Completed
 
Locations

Daugavpils Regional Hospital

Daugavpils, Latvia, LV-5417

Status
Completed
 
Locations

Central Hospital of Liepaja

Liepaja, Latvia, 3402

Status
Completed
 
Locations

University Country Hospital

Timisoara, Romania, 300748

Status
Completed
 
Locations

County Clinical Hospital

Brasov, Romania

Status
Completed
 
Locations

Clinical Emergency County Hospital

Cluj-Napoca, Romania, 400006

Status
Completed
 

Trial Design