check_circleStudy Completed

Infection

Therapy of Complicated Intra-Abdominal Infections with Moxifloxacin or Ertapenem

Trial purpose

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

Key Participants Requirements

Sex

Both

Age

18 Years
  • - 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
  • - 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

Trial summary

Enrollment Goal
804
Trial Dates
July 2006 - February 2009
Phase
Phase 3
Could I Receive a placebo
No
Products
Avelox (Moxifloxacin hydrochloride, BAY12-8039)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Kreiskrankenhaus BeeskowBeeskow, 15848, Germany
Completed
Universitätsklinikum des SaarlandesHomburg, 66424, Germany
Completed
Centre Hospitalier Montargoise - Amilly CedexAMILLY CEDEX, 45207, France
Completed
Hopital J. Minjoz - BesançonBESANCON, 25000, France
Completed
Ciutat Sanitària i Universitària de BellvitgeL'Hospitalet de Llobregat, 08907, Spain
Completed
Hospital General Universitario Gregorio MarañónMadrid, 28007, Spain
Completed
UZ GentGENT, 9000, Belgium
Completed
Hôpital Erasme/Erasmus ZiekenhuisBRUXELLES - BRUSSEL, 1070, Belgium
Completed
UZ BrusselBRUXELLES - BRUSSEL, 1090, Belgium
Completed
Vergelegen Medi-ClinicSomerset West, 7130, South Africa
Completed
Pretoria Academic Hospital Ethics CommitteePretoria, 0001, South Africa
Completed
University of StellenboschCAPE TOWN, 7500, South Africa
Completed
MHAT Ruse ADRousse, 7002, Bulgaria
Completed
UMHAT Dr. Georgi StranskiPleven, 5800, Bulgaria
Completed
Hospital de Agudos "Dr. Carlos Bocalandro"de Febrero 3, 1657, Argentina
Completed
Universitätsklinikum HeidelbergHeidelberg, 69120, Germany
Completed
Brüderkrankenhaus St. JosefPaderborn, 33098, Germany
Completed
Kliniken der Medizinischen Hochschule HannoverHannover, 30625, Germany
Completed
Meir Medical CenterKfar Saba, 4428164, Israel
Completed
Bnai Zion Medical CenterHaifa, 31048, Israel
Completed
Military Medical AcademySofia, 1431, Bulgaria
Completed
Multiprofile Hospital for Active Treatment and Emergency MedSofia, 1606, Bulgaria
Completed
Hosp. Municipal de Agudos "Mi Pueblo"Florencio Varela, 1888, Argentina
Completed
Sanatorio GüemesBuenos Aires, C1180AAX, Argentina
Completed
Hospital Zonal General de Agudos 'Heroes de Malvinas'Merlo, B1712FJN, Argentina
Completed
Hospital Zonal General de Agudo 'Dr. Ramón CarrilloCiudadela, B1702FWM, Argentina
Completed
Nuevo Hospital San RoqueCórdoba, 5000, Argentina
Completed
Hospital de Emergencias Clemente AlvarezRosario, Argentina
Completed
Smolensk Medical AcademySmolensk, 214019, Russia
Completed
Sanatorio San JoséCapital Federal, Argentina
Completed
Hospital CentralMendoza, Argentina
Completed
University General Hospital of PatrasRio Patras, 265 00, Greece
Completed
City Clinical Hospital no 13Moscow, 115280, Russia
Completed
1st Medical Academy Municipal Hospital N61Moscow, 119048, Russia
Completed
University Hospital of Vilnus CityVilnius, 10207, Lithuania
Completed
Klaipeda District HospitalKlaipeda, LT-92231, Lithuania
Completed
Regional Hospital of North EstoniaTallin, EE-13419, Estonia
Completed
Rezekne HospitalRezekne, Latvia
Completed
Fundeni Clinical InstituteBucharest, 022328, Romania
Completed
County Clinical HospitalOradea, Romania
Completed
Kaunas District HospitalKaunas, 45130, Lithuania
Completed
Vilnius University Hospital of Emergency CareVilnius, LT-04130, Lithuania
Completed
Tartu University ClinicsTartu, EE-51014, Estonia
Completed
Ida-Viru Central HospitalKohtla-Jarve, 30322, Estonia
Completed
Paula Stradina Kliniskas Universitates slimnicaRiga, 1002, Latvia
Completed
Valmiera HospitalValmiera, LV-4201, Latvia
Completed
Riga Clinical Hospital "Gailezers"Riga, LV-1038, Latvia
Completed
Daugavpils Regional HospitalDaugavpils, LV-5417, Latvia
Completed
Central Hospital of LiepajaLiepaja, 3402, Latvia
Completed
University Country HospitalTimisoara, 300748, Romania
Completed
County Clinical HospitalBrasov, Romania
Completed
Clinical Emergency County HospitalCluj-Napoca, 400006, Romania

Primary Outcome

  • Number of Subjects Achieving Clinical Cure at Test of Cure (TOC) Visit in the Per Protocol Population
    date_rangeTime Frame:
    21 to 28 days after completion of study drug therapy
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Number of Subjects Achieving Clinical Improvement During Treatment in the Per Protocol Population
    date_rangeTime Frame:
    During treatment at day 5 +/- 1 day
    enhanced_encryption
    Safety Issue:
    No
  • Number of Subjects Achieving Bacteriological Success During Treatment in the Per Protocol Population With Causative Organism(s)
    date_rangeTime Frame:
    During treatment at day 5 +/- 1 day
    enhanced_encryption
    Safety Issue:
    No
  • Number of Subjects Achieving Clinical Cure at End of Therapy (EOT) Visit in the Per Protocol Population
    date_rangeTime Frame:
    after 5 - 14 days of therapy
    enhanced_encryption
    Safety Issue:
    No
  • Number of Subjects Achieving Bacteriological Success at EOT Visit in the Per Protocol Population With Causative Organism(s)
    date_rangeTime Frame:
    After 5 - 14 days of therapy
    enhanced_encryption
    Safety Issue:
    No
  • Number of Subjects Achieving Bacteriological Success at TOC Visit in the Per Protocol Population With Causative Organism(s)
    date_rangeTime Frame:
    21 - 28 days after end of therapy
    enhanced_encryption
    Safety Issue:
    No
  • Number of Subjects Achieving Clinical Cure at TOC Visit in the Per Protocol Population With Causative Organism(s)
    date_rangeTime Frame:
    21 - 28 days after end of therapy
    enhanced_encryption
    Safety Issue:
    No
  • Number of Subjects Who Died Due to Intra-abdominal Infections
    date_rangeTime Frame:
    21 - 28 days after end of treatment at TOC Visit
    enhanced_encryption
    Safety Issue:
    No
  • Duration of Hospitalization
    date_rangeTime Frame:
    From the first admission date to the discharge date (from 4 to 71 days after start of study medication)
    enhanced_encryption
    Safety Issue:
    No
  • Duration of Hospitalization Postoperatively
    date_rangeTime Frame:
    Duration of hospitalization after the first surgery until discharge date (from 4 to 71 days after start of study medication)
    enhanced_encryption
    Safety Issue:
    No

Trial design

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)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2