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Sponsors and Collaborators: |
Hannover Medical School Bayer AG Leverkusen |
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Information provided by: | Hannover Medical School |
ClinicalTrials.gov Identifier: | NCT00629135 |
The study is contemplating the antibiotic therapy of intraabdominal abscesses. These abscesses are a serious problem in surgical practice. Associated pathophysiologic effects as for example peritonitis may become life threatening or may lead to extended periods of morbidity with prolonged hospitalization.
The objective of the sudy is to evaluate whether the combination of Moxifloxacin and Metronidazole is equivalent to Piperacillin / Tazobactam with regard to clinical outcome and eradication of aerobe and anaerobe pathogens in patients with intra-abdominal abscesses.
Condition | Intervention | Phase |
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Abscess, Intra-Abdominal |
Drug: Moxifloxacin/Metronidazole or Piperacillin/Tazobactam |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Single Centre, Prospective, Comparative, Open-Label, Randomised Study to Evaluate the Efficacy and Tolerability of the Combination of Moxifloxacin Plus Metronidazole Versus Piperacillin/Tazobactam for the Treatment of Patients With Intra-Abdominal Abscesses |
Estimated Enrollment: | 180 |
Study Start Date: | November 2005 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
For adult patients with intra-abdominal abscesses matching the criteria to be included will and enrolled in the study arm 1: Moxifloxacin 400 mg, administered intravenously once daily in combination with Metronidazole 500 mg, administered two times daily intravenously, followed by an oral medication with Moxifloxacin 400 mg once daily and Metronidazole 500 mg twice daily.
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Drug: Moxifloxacin/Metronidazole or Piperacillin/Tazobactam
Antibiotic therapy for patients with intra-abdominal abscesses; Intervention consists of antibiotic treatment of the patients with intraabdominal abscess with either the combination of Moxifloxacin and Metronidazole or Piperacillin/Tazobactam.1. Moxifloxacin 400 mg, administered intravenously once daily in combination with Metronidazole 500 mg, administered two times daily intravenously, followed by an oral medication with Moxifloxacin 400 mg once daily and Metronidazole 500 mg twice daily. 2. Piperacillin / Tazobactam 4,5 g administered intravenously three times daily.
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2: Active Comparator
For adult patients with intra-abdominal abscesses matching the criteria to be included will and enrolled in the study arm 2: Piperacillin / Tazobactam 4,5 g administered intravenously three times daily
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Drug: Moxifloxacin/Metronidazole or Piperacillin/Tazobactam
Antibiotic therapy for patients with intra-abdominal abscesses; Intervention consists of antibiotic treatment of the patients with intraabdominal abscess with either the combination of Moxifloxacin and Metronidazole or Piperacillin/Tazobactam.1. Moxifloxacin 400 mg, administered intravenously once daily in combination with Metronidazole 500 mg, administered two times daily intravenously, followed by an oral medication with Moxifloxacin 400 mg once daily and Metronidazole 500 mg twice daily. 2. Piperacillin / Tazobactam 4,5 g administered intravenously three times daily.
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The study is an interventional prospective, comparative, open-label, randomised single-centre study. Adult patients with intra-abdominal abscesses matching the criteria to be included will be enrolled in the study and randomised into one of the Groups: 1. Moxifloxacin 400 mg, administered intravenously once daily in combination with Metronidazole 500 mg, administered two times daily intravenously, followed by an oral medication with Moxifloxacin 400 mg once daily and Metronidazole 500 mg twice daily. 2. Piperacillin / Tazobactam 4,5 g administered intravenously three times daily.
Primary study endpoints: Clinical success / failure rate at the Test-of-Cure visit.
Secondary study endpoints: -Bacteriological response at TOC, -Clinical + Bacteriological response at End-of-Treatment-visit, - Course of disease on the basis of clinical and laboratory parameters, -Time to discharge from hospitals, -Duration of hospitalization post-operatively, - safety and tolerability of the study medication, -cost effectiveness of treatment regimes.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A) Laparotomy revealing intra-abdominal abscess or macroscopic gastrointestinal perforation OR
B) Suspected intra-abdominal abscess and scheduled for operation with at least three of the following criteria:
Exclusion Criteria:
Patients with the following:
Contact: Michael Winkler, Prof | 0049-511-5324659 | Winkler.Michael@MH-Hannover.DE |
Contact: Holger Kespohl | 0049-511-5326924 | Kespohl.Holger@MH-Hannover.DE |
Germany | |
Medical School Hannover | Recruiting |
Hannover, Germany, 30625 | |
Contact: Beate Heins-Hoentsch 0049-511-5326924 |
Principal Investigator: | Michael Winkler, Prof | Medical School Hannover, Department for abdominal and transplant surgery |
Responsible Party: | Medical School Hannover, Department for abdominal and transplant surgery ( Prof. Dr. med. Michael Winkler ) |
Study ID Numbers: | MHH-MW-01 |
Study First Received: | February 25, 2008 |
Last Updated: | March 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00629135 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
abscess intraabdominal abscess Moxifloxacine Moxifloxacin Metronidazole |
Tazobactam Piperacilline Piperacillin Tazobac |
Metronidazole Abdominal Abscess Penicillanic Acid Moxifloxacin Abscess |
Suppuration Tazobactam Piperacillin Piperacillin-tazobactam combination product Inflammation |
Anti-Infective Agents Anti-Bacterial Agents Antiparasitic Agents Antiprotozoal Agents Pathologic Processes Molecular Mechanisms of Pharmacological Action |
Radiation-Sensitizing Agents Therapeutic Uses Physiological Effects of Drugs Enzyme Inhibitors Infection Pharmacologic Actions |