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

Primary Purpose

Abscess, Intra-Abdominal

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Moxifloxacin/Metronidazole or Piperacillin/Tazobactam
Sponsored by
Hannover Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abscess, Intra-Abdominal focused on measuring abscess, intraabdominal abscess, Moxifloxacine, Moxifloxacin, Metronidazole, Tazobactam, Piperacilline, Piperacillin, Tazobac

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical School Hannover

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Clinical success / failure rate at the Test-of-Cure visit
clinical success

Secondary Outcome Measures

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

Full Information

First Posted
February 25, 2008
Last Updated
July 20, 2018
Sponsor
Hannover Medical School
Collaborators
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT00629135
Brief Title
Moxifloxacin Plus Metronidazole Versus Piperacillin/Tazobactam for the Treatment of Patients With Intra-abdominal Abscesses
Acronym
MEMO
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 Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
November 15, 2005 (Actual)
Primary Completion Date
August 15, 2011 (Actual)
Study Completion Date
August 15, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hannover Medical School
Collaborators
Bayer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abscess, Intra-Abdominal
Keywords
abscess, intraabdominal abscess, Moxifloxacine, Moxifloxacin, Metronidazole, Tazobactam, Piperacilline, Piperacillin, Tazobac

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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.
Arm Title
2
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin/Metronidazole or Piperacillin/Tazobactam
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical success / failure rate at the Test-of-Cure visit
Description
clinical success
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Clinical + Bacteriological response at End-of-Treatment-visit
Description
microbiology
Time Frame
14 days
Title
Time to discharge from hospital
Description
hospital stay
Time Frame
up to several months
Title
Course of disease on the basis of clinical and laboratory parameters
Description
response to treatment
Time Frame
several days
Title
safety and tolerability of the study medication
Description
recording of side effects od study medication such as cardiac arrythmias
Time Frame
4 to 10 days
Title
cost effectiveness of treatment regimes
Description
total costs of hospital stay
Time Frame
up to several months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Winkler, Prof
Organizational Affiliation
Medical School Hannover, Department for abdominal and transplant surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical School Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany

12. IPD Sharing Statement

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

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