BAY12-8039, iv/Oral Pulmonary Abscess/Aspiration Pneumonia

January 8, 2010 updated by: Bayer

Prospective, Multi-center, Randomized, Non-blind Trial to Assess the Efficacy and Safety of Moxifloxacin Versus Sulbactam/Ampicillin in the Treatment of Pulmonary Abscess and Aspiration Pneumonia

The purpose of this trial is to determine the efficacy and safety of Moxifloxacin in comparison to Sulbactam/Ampicillin in the treatment of pulmonary abscesses and aspiration pneumonia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

139

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 13353
      • Berlin, Germany, 14165
    • Baden-Württemberg
      • Mannheim, Baden-Württemberg, Germany, 68167
    • Bayern
      • Nürnberg, Bayern, Germany, 90419
      • Regensburg, Bayern, Germany, 93053
    • Brandenburg
      • Treuenbrietzen, Brandenburg, Germany, 14929
    • Hessen
      • Frankfurt, Hessen, Germany, 60596
    • Niedersachsen
      • Hildesheim, Niedersachsen, Germany, 31134
      • Rotenburg, Niedersachsen, Germany, 27356
    • Nordrhein-Westfalen
      • Lüdenscheid, Nordrhein-Westfalen, Germany, 58515
      • Oberhausen, Nordrhein-Westfalen, Germany, 46045
      • Paderborn, Nordrhein-Westfalen, Germany, 33098
    • Sachsen
      • Leipzig, Sachsen, Germany, 04129
    • Sachsen-Anhalt
      • Magdeburg, Sachsen-Anhalt, Germany, 39112
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, 23538

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female patients aged 18 years or above
  • The primary diagnosis is community or hospital acquired primary pulmonary abscess or aspiration pneumonia, requiring initial parenteral treatment

Exclusion Criteria:

  • Known hypersensitivity to fluoroquinolones and/or ß-lactams
  • Patients with mechanical ventilation lasting more than 48 hours prior to enrollment, with poststenotic pneumonia, infarction pneumonia, pulmonary tuberculosis, lung abscess/pneumonia with concomitant endocarditis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 2
Drug: Sulbactam/Ampicillin
Sulbactam/Ampicillin, 3 g iv, tid, switch after 18 doses (6 days) to 750 mg Sulbactam/Ampicillin oral, bid
Experimental: Arm 1
Drug: Avelox (Moxifloxacin, BAY12-8039)
Moxifloxacin, 400 mg iv, od, switch after 6 doses (6 days) to 400 mg Moxifloxacin oral, od

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse events occuring after first application of study medication up to the test of cure visit for non-serious adverse events
Time Frame: Up to 30 days after end of treatment with study medication for serious adverse events
Up to 30 days after end of treatment with study medication for serious adverse events

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical Response
Time Frame: Regulary doing i.v. treatment
Regulary doing i.v. treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2001

Study Completion (Actual)

January 1, 2005

Study Registration Dates

First Submitted

January 8, 2010

First Submitted That Met QC Criteria

January 8, 2010

First Posted (Estimate)

January 11, 2010

Study Record Updates

Last Update Posted (Estimate)

January 11, 2010

Last Update Submitted That Met QC Criteria

January 8, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10381 (Registry Identifier: DAIDS ES Registry Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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