Clinical Trial: Moxifloxacin Plus Metronidazole Versus Piperacillin/Tazobactam for the Treatment of Patients With Intra-abdominal Abscesses

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

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.

Detailed Summary:

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.

Sponsor: Hannover Medical School

Current Primary Outcome: Clinical success / failure rate at the Test-of-Cure visit [ Time Frame: 14 days ]

Original Primary Outcome: Clinical success / failure rate at the Test-of-Cure visit

Current Secondary Outcome:

• Clinical + Bacteriological response at End-of-Treatment-visit [ Time Frame: 14 days ]
  microbiology
• Time to discharge from hospital [ Time Frame: up to several months ]
  hospital stay
• Course of disease on the basis of clinical and laboratory parameters [ Time Frame: several days ]
  response to treatment
• safety and tolerability of the study medication [ Time Frame: 4 to 10 days ]
  recording of side effects od study medication such as cardiac arrythmias
• cost effectiveness of treatment regimes [ Time Frame: up to several months ]
  total costs of hospital stay

Original Secondary Outcome:

• Clinical + Bacteriological response at End-of-Treatment-visit
• Time to discharge from hospital
• Course of disease on the basis of clinical and laboratory parameters
• safety and tolerability of the study medication
• cost effectiveness of treatment regimes

Information By: Hannover Medical School

Dates:
Date Received: February 25, 2008
Date Started: November 2005
Date Completion: August 2012
Last Updated: June 21, 2011
Last Verified: May 2010