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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Hannover Medical School.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Bayer
Information provided by:
Hannover Medical School
ClinicalTrials.gov Identifier:
NCT00629135
First received: February 25, 2008
Last updated: June 21, 2011
Last verified: May 2010

February 25, 2008
June 21, 2011
November 2005
February 2012   (final data collection date for primary outcome measure)
Clinical success / failure rate at the Test-of-Cure visit [ Time Frame: 14 days ] [ Designated as safety issue: No ]
clinical success
Clinical success / failure rate at the Test-of-Cure visit
Complete list of historical versions of study NCT00629135 on ClinicalTrials.gov Archive Site
  • 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
  • Clinical + Bacteriological response at End-of-Treatment-visit
  • Time 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
Not Provided
Not Provided
 
Moxifloxacin Plus Metronidazole Versus Piperacillin/Tazobactam for the Treatment of Patients With Intra-abdominal Abscesses
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Abscess, Intra-Abdominal
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.
  • 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.
    Intervention: Drug: Moxifloxacin/Metronidazole or Piperacillin/Tazobactam
  • 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
    Intervention: Drug: Moxifloxacin/Metronidazole or Piperacillin/Tazobactam
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
180
August 2012
February 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Michael Winkler, Prof 0049-511-5324659 Winkler.Michael@MH-Hannover.DE
Contact: Holger Kespohl 0049-511-5326924 Kespohl.Holger@MH-Hannover.DE
Germany
 
NCT00629135
MHH-MW-01
Yes
Prof. Dr. med. Michael Winkler, Medical School Hannover, Department for abdominal and transplant surgery
Hannover Medical School
Bayer
Principal Investigator: Michael Winkler, Prof Medical School Hannover, Department for abdominal and transplant surgery
Hannover Medical School
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP