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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01045902
First Posted: January 11, 2010
Last Update Posted: January 11, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bayer
  Purpose
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.

Condition Intervention Phase
Pneumonia, Aspiration Lung Abscess Drug: Avelox (Moxifloxacin, BAY12-8039) Drug: Sulbactam/Ampicillin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Clinical Response [ Time Frame: Regulary doing i.v. treatment ]

Enrollment: 139
Study Start Date: February 2001
Study Completion Date: January 2005
Arms Assigned Interventions
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
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01045902


Locations
Germany
Mannheim, Baden-Württemberg, Germany, 68167
Nürnberg, Bayern, Germany, 90419
Regensburg, Bayern, Germany, 93053
Treuenbrietzen, Brandenburg, Germany, 14929
Frankfurt, Hessen, Germany, 60596
Hildesheim, Niedersachsen, Germany, 31134
Rotenburg, Niedersachsen, Germany, 27356
Lüdenscheid, Nordrhein-Westfalen, Germany, 58515
Oberhausen, Nordrhein-Westfalen, Germany, 46045
Paderborn, Nordrhein-Westfalen, Germany, 33098
Magdeburg, Sachsen-Anhalt, Germany, 39112
Leipzig, Sachsen, Germany, 04129
Lübeck, Schleswig-Holstein, Germany, 23538
Berlin, Germany, 13353
Berlin, Germany, 14165
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT01045902     History of Changes
Other Study ID Numbers: 10381
First Submitted: January 8, 2010
First Posted: January 11, 2010
Last Update Posted: January 11, 2010
Last Verified: January 2010

Keywords provided by Bayer:
Pulmonary Abscess
Aspiration Pneumonia

Additional relevant MeSH terms:
Pneumonia
Abscess
Pneumonia, Aspiration
Lung Abscess
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Suppuration
Infection
Inflammation
Pathologic Processes
Moxifloxacin
Fluoroquinolones
Ampicillin
Sulbactam
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Nucleic Acid Synthesis Inhibitors