check_circleStudy Completed
Infection
Bayer Identifier:
11976
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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
BothAge
18 YearsTrial summary
Enrollment Goal
804Trial Dates
July 2006 - February 2009Phase
Phase 3Could I Receive a placebo
NoProducts
Avelox (Moxifloxacin hydrochloride, BAY12-8039)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Kreiskrankenhaus Beeskow | Beeskow, 15848, Germany |
Completed | Universitätsklinikum des Saarlandes | Homburg, 66424, Germany |
Completed | Centre Hospitalier Montargoise - Amilly Cedex | AMILLY CEDEX, 45207, France |
Completed | Hopital J. Minjoz - Besançon | BESANCON, 25000, France |
Completed | Ciutat Sanitària i Universitària de Bellvitge | L'Hospitalet de Llobregat, 08907, Spain |
Completed | Hospital General Universitario Gregorio Marañón | Madrid, 28007, Spain |
Completed | UZ Gent | GENT, 9000, Belgium |
Completed | Hôpital Erasme/Erasmus Ziekenhuis | BRUXELLES - BRUSSEL, 1070, Belgium |
Completed | UZ Brussel | BRUXELLES - BRUSSEL, 1090, Belgium |
Completed | Vergelegen Medi-Clinic | Somerset West, 7130, South Africa |
Completed | Pretoria Academic Hospital Ethics Committee | Pretoria, 0001, South Africa |
Completed | University of Stellenbosch | CAPE TOWN, 7500, South Africa |
Completed | MHAT Ruse AD | Rousse, 7002, Bulgaria |
Completed | UMHAT Dr. Georgi Stranski | Pleven, 5800, Bulgaria |
Completed | Hospital de Agudos "Dr. Carlos Bocalandro" | de Febrero 3, 1657, Argentina |
Completed | Universitätsklinikum Heidelberg | Heidelberg, 69120, Germany |
Completed | Brüderkrankenhaus St. Josef | Paderborn, 33098, Germany |
Completed | Kliniken der Medizinischen Hochschule Hannover | Hannover, 30625, Germany |
Completed | Meir Medical Center | Kfar Saba, 4428164, Israel |
Completed | Bnai Zion Medical Center | Haifa, 31048, Israel |
Completed | Military Medical Academy | Sofia, 1431, Bulgaria |
Completed | Multiprofile Hospital for Active Treatment and Emergency Med | Sofia, 1606, Bulgaria |
Completed | Hosp. Municipal de Agudos "Mi Pueblo" | Florencio Varela, 1888, Argentina |
Completed | Sanatorio Güemes | Buenos Aires, C1180AAX, Argentina |
Completed | Hospital Zonal General de Agudos 'Heroes de Malvinas' | Merlo, B1712FJN, Argentina |
Completed | Hospital Zonal General de Agudo 'Dr. Ramón Carrillo | Ciudadela, B1702FWM, Argentina |
Completed | Nuevo Hospital San Roque | Córdoba, 5000, Argentina |
Completed | Hospital de Emergencias Clemente Alvarez | Rosario, Argentina |
Completed | Smolensk Medical Academy | Smolensk, 214019, Russia |
Completed | Sanatorio San José | Capital Federal, Argentina |
Completed | Hospital Central | Mendoza, Argentina |
Completed | University General Hospital of Patras | Rio Patras, 265 00, Greece |
Completed | City Clinical Hospital no 13 | Moscow, 115280, Russia |
Completed | 1st Medical Academy Municipal Hospital N61 | Moscow, 119048, Russia |
Completed | University Hospital of Vilnus City | Vilnius, 10207, Lithuania |
Completed | Klaipeda District Hospital | Klaipeda, LT-92231, Lithuania |
Completed | Regional Hospital of North Estonia | Tallin, EE-13419, Estonia |
Completed | Rezekne Hospital | Rezekne, Latvia |
Completed | Fundeni Clinical Institute | Bucharest, 022328, Romania |
Completed | County Clinical Hospital | Oradea, Romania |
Completed | Kaunas District Hospital | Kaunas, 45130, Lithuania |
Completed | Vilnius University Hospital of Emergency Care | Vilnius, LT-04130, Lithuania |
Completed | Tartu University Clinics | Tartu, EE-51014, Estonia |
Completed | Ida-Viru Central Hospital | Kohtla-Jarve, 30322, Estonia |
Completed | Paula Stradina Kliniskas Universitates slimnica | Riga, 1002, Latvia |
Completed | Valmiera Hospital | Valmiera, LV-4201, Latvia |
Completed | Riga Clinical Hospital "Gailezers" | Riga, LV-1038, Latvia |
Completed | Daugavpils Regional Hospital | Daugavpils, LV-5417, Latvia |
Completed | Central Hospital of Liepaja | Liepaja, 3402, Latvia |
Completed | University Country Hospital | Timisoara, 300748, Romania |
Completed | County Clinical Hospital | Brasov, Romania |
Completed | Clinical Emergency County Hospital | Cluj-Napoca, 400006, Romania |
Primary Outcome
- Number of Subjects Achieving Clinical Cure at Test of Cure (TOC) Visit in the Per Protocol Populationdate_rangeTime Frame:21 to 28 days after completion of study drug therapyenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Number of Subjects Achieving Clinical Improvement During Treatment in the Per Protocol Populationdate_rangeTime Frame:During treatment at day 5 +/- 1 dayenhanced_encryptionNoSafety Issue:
- 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 dayenhanced_encryptionNoSafety Issue:
- Number of Subjects Achieving Clinical Cure at End of Therapy (EOT) Visit in the Per Protocol Populationdate_rangeTime Frame:after 5 - 14 days of therapyenhanced_encryptionNoSafety Issue:
- 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 therapyenhanced_encryptionNoSafety Issue:
- 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 therapyenhanced_encryptionNoSafety Issue:
- 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 therapyenhanced_encryptionNoSafety Issue:
- Number of Subjects Who Died Due to Intra-abdominal Infectionsdate_rangeTime Frame:21 - 28 days after end of treatment at TOC Visitenhanced_encryptionNoSafety Issue:
- Duration of Hospitalizationdate_rangeTime Frame:From the first admission date to the discharge date (from 4 to 71 days after start of study medication)enhanced_encryptionNoSafety Issue:
- Duration of Hospitalization Postoperativelydate_rangeTime Frame:Duration of hospitalization after the first surgery until discharge date (from 4 to 71 days after start of study medication)enhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2Additional Information
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