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Moxifloxacin Plus Metronidazole Versus Piperacillin/Tazobactam for the Treatment of Patients With Intra-abdominal Abscesses (MEMO)
This study is currently recruiting participants.
Verified May 2010 by Hannover Medical School

First Received on February 25, 2008.   Last Updated on June 21, 2011   History of Changes
Sponsor: Hannover Medical School
Collaborator: Bayer
Information provided by: Hannover Medical School
ClinicalTrials.gov Identifier: NCT00629135
  Purpose

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.


Condition Intervention Phase
Abscess, Intra-Abdominal
 Drug: Moxifloxacin/Metronidazole or Piperacillin/Tazobactam
 Phase III

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics
Drug Information available for: Piperacillin sodium Piperacillin Metronidazole hydrochloride Metronidazole phosphate Tazobactam Moxifloxacin Moxifloxacin hydrochloride Metronidazole
U.S. FDA Resources

Further study details as provided by Hannover Medical School:

Primary Outcome Measures:
  • Clinical success / failure rate at the Test-of-Cure visit [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    clinical success


Secondary Outcome Measures:
  • Clinical + Bacteriological response at End-of-Treatment-visit [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    microbiology

  • Time to discharge from hospital [ Time Frame: up to several months ] [ Designated as safety issue: No ]
    hospital stay

  • Course of disease on the basis of clinical and laboratory parameters [ Time Frame: several days ] [ Designated as safety issue: No ]
    response to treatment

  • safety and tolerability of the study medication [ Time Frame: 4 to 10 days ] [ Designated as safety issue: Yes ]
    recording of side effects od study medication such as cardiac arrythmias

  • cost effectiveness of treatment regimes [ Time Frame: up to several months ] [ Designated as safety issue: No ]
    total costs of hospital stay


Estimated Enrollment: 180
Study Start Date: November 2005
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00629135

Contacts
Contact: Michael Winkler, Prof 0049-511-5324659 Winkler.Michael@MH-Hannover.DE
Contact: Holger Kespohl 0049-511-5326924 Kespohl.Holger@MH-Hannover.DE

Locations
Germany
Medical School Hannover Recruiting
Hannover, Germany, 30625
Contact: Beate Heins-Hoentsch     0049-511-5326924        
Sponsors and Collaborators
Hannover Medical School
Bayer
Investigators
Principal Investigator: Michael Winkler, Prof Medical School Hannover, Department for abdominal and transplant surgery
  More Information

No publications provided

Responsible Party: Prof. Dr. med. Michael Winkler, Medical School Hannover, Department for abdominal and transplant surgery
ClinicalTrials.gov Identifier: NCT00629135     History of Changes
Other Study ID Numbers: MHH-MW-01
Study First Received: February 25, 2008
Last Updated: June 21, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Hannover Medical School:
abscess
intraabdominal abscess
Moxifloxacine
Moxifloxacin
Metronidazole
 Tazobactam
Piperacilline
Piperacillin
Tazobac

Additional relevant MeSH terms:
Abscess
Abdominal Abscess
Suppuration
Infection
Inflammation
Pathologic Processes
Piperacillin
Penicillanic Acid
Piperacillin-tazobactam combination product
Moxifloxacin
Metronidazole
Tazobactam
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
 Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antiprotozoal Agents
Antiparasitic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on February 09, 2012



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