Moxifloxacin Plus Metronidazole Versus Piperacillin/Tazobactam for the Treatment of Patients With Intra-abdominal Abscesses
Moxifloxacin Plus Metronidazole Versus Piperacillin/Tazobactam for the Treatment of Patients With Intra-abdominal Abscesses
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.
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.
Inclusion Criteria:

 -  Patients who attained full age (18 years) with intra-abdominal abscesses documented
 by:

 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:

 -  fever,

 -  leucocytosis,

 -  symptoms referable to the abdominal cavity (nausea, pain),

 -  tenderness with or without rebound / abdominal wall rigidity,

 -  radiological evidence for abscess or gastrointestinal perforation.

 Exclusion Criteria:

 -  Patients with the following:

 -  indwelling peritoneal catheter,

 -  presumed spontaneous bacterial peritonits,

 -  peripancreatic sepsis or infection secondary to pancreatitis,

 -  peptic or traumatic perforation of gastrointestinal tract of < 24 h duration,

 -  traumatic perforation of the small or large bowel of < 12h duration,

 -  transmural necrosis of the intestine due to acute embolic, thrombotic or
 obstructive occlusions,

 -  acute cholecystitis,

 -  appendicitis without perforation or abscess,

 -  required open abdomen techniques for management,

 -  gynaecological infection,

 -  known hypersensivity to any of the study drugs,

 -  lifethreatening disease with life expectancy of less than 48 hours,

 -  neutropenia with neutrophil count < 1000 cells/µl,

 -  receiving chronic treatment with imunosuppressant therapy,

 -  HIV-seropositives with CD4 count < 200 cells/µl,

 -  end stage hepatic cirrhosis CHILD PUGH C,

 -  central or peripheral neuropathy,

 -  bradycardia,

 -  symptomatic dysrhythmia in medical history,

 -  syndromes of QTc prolongation or use of concomittant medicaments reported to
 increase QT interval,

 -  disorder of the electrolyte balance,

 -  previous history of tendinopathy with quinolones,

 -  previously enrolled in the trial or use of any investigational drug within the
 previous 30 days