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

NCT00629135 | Completed Phase 3 DMC

• 1 other identifier: MHH-MW-01
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Abscess, Intra-Abdominal

Keywords

abscess; intraabdominal abscess; Moxifloxacine; Moxifloxacin; Metronidazole; Tazobactam; Piperacilline; Piperacillin; Tazobac

Outcome Measures

Primary Outcomes (1)

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

  clinical success

  14 days

Secondary Outcomes (5)

• Clinical + Bacteriological response at End-of-Treatment-visit

  14 days

• Time to discharge from hospital

  up to several months

• Course of disease on the basis of clinical and laboratory parameters

  several days

• safety and tolerability of the study medication

  4 to 10 days

• cost effectiveness of treatment regimes

  up to several months

Study Arms (2)

1

EXPERIMENTAL

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

2

ACTIVE COMPARATOR

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

Interventions

Moxifloxacin/Metronidazole or Piperacillin/Tazobactam DRUG

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.

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Hannover Medical School: lead
• Bayer: collaborator

Study Sites (1)

Medical School Hannover

Hanover, 30625, Germany

Location

MeSH Terms

Conditions

Abdominal Abscess; Abscess

Interventions

Moxifloxacin; Metronidazole; Piperacillin, Tazobactam Drug Combination

Condition Hierarchy (Ancestors)

Suppuration; Infections; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Tazobactam; Penicillanic Acid; Penicillins; beta-Lactams; Lactams; Amides; Piperacillin; Ampicillin; Penicillin G; Sulfur Compounds; Sulfones; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Michael Winkler, Prof

  Medical School Hannover, Department for abdominal and transplant surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2008
• First Posted: March 5, 2008
• Study Start: November 15, 2005
• Primary Completion: August 15, 2011
• Study Completion: August 15, 2011
• Last Updated: July 24, 2018

Record last verified: 2018-07

Locations

DE (1)