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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

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

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

NCT ID

NCT00629135

First Posted

February 25, 2008

Last Updated

July 20, 2018

Sponsor

Hannover Medical School

Collaborators

Bayer

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

Arm Type

Experimental

Arm Description

Arm Title

Arm Type

Active Comparator

Arm Description

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

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

Learn more about this trial

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

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