Moxifloxacin Plus Metronidazole Versus Piperacillin/Tazobactam for the Treatment of Patients With Intra-abdominal Abscesses (MEMO)

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

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.

Study Overview

• Status: Completed
• Conditions: Abscess, Intra-Abdominal
• Intervention / Treatment: Drug: Moxifloxacin/Metronidazole or Piperacillin/Tazobactam

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.

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Hannover, Germany, 30625
    • Medical School Hannover

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; For adult patients with intra-abdominal abscesses matching the criteria to be included will and enrolled in the study arm 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.	Drug: Moxifloxacin/Metronidazole or Piperacillin/Tazobactam; Antibiotic therapy for patients with intra-abdominal abscesses; Intervention consists of antibiotic treatment of the patients with intraabdominal abscess with either the combination of Moxifloxacin and Metronidazole or Piperacillin/Tazobactam.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.
Active Comparator: 2; For adult patients with intra-abdominal abscesses matching the criteria to be included will and enrolled in the study arm 2: Piperacillin / Tazobactam 4,5 g administered intravenously three times daily	Drug: Moxifloxacin/Metronidazole or Piperacillin/Tazobactam; Antibiotic therapy for patients with intra-abdominal abscesses; Intervention consists of antibiotic treatment of the patients with intraabdominal abscess with either the combination of Moxifloxacin and Metronidazole or Piperacillin/Tazobactam.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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical success / failure rate at the Test-of-Cure visit	clinical success	14 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hannover Medical School
• Collaborators: Bayer
• Investigators: Principal Investigator: Michael Winkler, Prof, Medical School Hannover, Department for abdominal and transplant surgery

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2005
• Primary Completion (Actual): August 15, 2011
• Study Completion (Actual): August 15, 2011

Study Registration Dates

• First Submitted: February 25, 2008
• First Submitted That Met QC Criteria: March 4, 2008
• First Posted (Estimate): March 5, 2008

Study Record Updates

• Last Update Posted (Actual): July 24, 2018
• Last Update Submitted That Met QC Criteria: July 20, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Metronidazole; Moxifloxacin; abscess; Piperacillin; Tazobactam; intraabdominal abscess; Moxifloxacine; Piperacilline; Tazobac
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Inflammation; Suppuration; Abscess; Abdominal Abscess; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; beta-Lactamase Inhibitors; Moxifloxacin; Metronidazole; Piperacillin; Tazobactam; Piperacillin, Tazobactam Drug Combination
• Other Study ID Numbers: MHH-MW-01