Moxifloxacin Plus Metronidazole Versus Piperacillin/Tazobactam for the Treatment of Patients With Intra-abdominal Abscesses
Information source: Hannover Medical School
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Abscess, Intra-Abdominal
Intervention: Moxifloxacin/Metronidazole or Piperacillin/Tazobactam (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Hannover Medical School Official(s) and/or principal investigator(s):
Michael Winkler, Prof, Principal Investigator, Affiliation: Medical School Hannover, Department for abdominal and transplant surgery
Overall contact:
Michael Winkler, Prof, Phone: 0049-511-5324659, Email: Winkler.Michael@MH-Hannover.DE
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Clinical success / failure rate at the Test-of-Cure visit
Secondary outcome: Clinical + Bacteriological response at End-of-Treatment-visitTime 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
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Michael Winkler, Prof, Phone: 0049-511-5324659, Email: Winkler.Michael@MH-Hannover.DE
Medical School Hannover, Hannover 30625, Germany; Recruiting
Beate Heins-Hoentsch, Phone: 0049-511-5326924
Additional Information
Starting date: November 2005
Last updated: June 21, 2011
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