Status:
COMPLETED
Moxifloxacin Plus Metronidazole Versus Piperacillin/Tazobactam for the Treatment of Patients With Intra-abdominal Abscesses
Lead Sponsor:
Hannover Medical School
Collaborating Sponsors:
Bayer
Conditions:
Abscess, Intra-Abdominal
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 peritoniti...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 15 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 15 2011
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00629135
Start Date
November 15 2005
End Date
August 15 2011
Last Update
July 24 2018
Active Locations (1)
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1
Medical School Hannover
Hanover, Germany, 30625