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Tracking Information | |||||||||
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First Received Date † | February 25, 2008 | ||||||||
Last Updated Date | March 4, 2008 | ||||||||
Start Date † | November 2005 | ||||||||
Current Primary Outcome Measures † |
Clinical success / failure rate at the Test-of-Cure visit | ||||||||
Original Primary Outcome Measures † | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT00629135 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||||||
Descriptive Information | |||||||||
Brief Title † | Moxifloxacin Plus Metronidazole Versus Piperacillin/Tazobactam for the Treatment of Patients With Intra-Abdominal Abscesses | ||||||||
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 | ||||||||
Brief Summary | 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. |
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Detailed Description | 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. |
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Study Phase | Phase III | ||||||||
Study Type † | Interventional | ||||||||
Study Design † | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study | ||||||||
Condition † | Abscess, Intra-Abdominal | ||||||||
Intervention † | Drug: Moxifloxacin/Metronidazole or Piperacillin/Tazobactam | ||||||||
Study Arms / Comparison Groups |
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Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status † | Recruiting | ||||||||
Estimated Enrollment † | 180 | ||||||||
Estimated Completion Date | August 2009 | ||||||||
Estimated Primary Completion Date | February 2009 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria † | 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:
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Gender | Both | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts †† |
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Location Countries † | Germany | ||||||||
Expanded Access Status | |||||||||
Administrative Information | |||||||||
NCT ID † | NCT00629135 | ||||||||
Responsible Party | Prof. Dr. med. Michael Winkler, Medical School Hannover, Department for abdominal and transplant surgery | ||||||||
Secondary IDs †† | |||||||||
Study Sponsor † | Hannover Medical School | ||||||||
Collaborators †† | Bayer AG Leverkusen | ||||||||
Investigators † |
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Information Provided By | Hannover Medical School | ||||||||
Verification Date | February 2008 | ||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |