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

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. Identifier: NCT01045902
Recruitment Status : Completed
First Posted : January 11, 2010
Last Update Posted : January 11, 2010
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Pneumonia, Aspiration Lung Abscess Drug: Avelox (Moxifloxacin, BAY12-8039) Drug: Sulbactam/Ampicillin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 139 participants
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
Study Start Date : February 2001
Actual Study Completion Date : January 2005

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. Clinical Response [ Time Frame: Regulary doing i.v. treatment ]

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT01045902

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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
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Study Director: Bayer Study Director Bayer

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Responsible Party: Therapeutic Area Head, Bayer HealthCare AG Identifier: NCT01045902     History of Changes
Other Study ID Numbers: 10381
First Posted: January 11, 2010    Key Record Dates
Last Update Posted: January 11, 2010
Last Verified: January 2010
Keywords provided by Bayer:
Pulmonary Abscess
Aspiration Pneumonia
Additional relevant MeSH terms:
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Lung Abscess
Pneumonia, Aspiration
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Pathologic Processes
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
beta-Lactamase Inhibitors