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

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