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Trial record 1 of 10 for:    "Pneumonia, Aspiration"
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BAY12-8039, iv/Oral Pulmonary Abscess/Aspiration Pneumonia

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01045902
First received: January 8, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Response [ Time Frame: Regulary doing i.v. treatment ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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, 14165
Berlin, Germany, 13353
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT01045902     History of Changes
Other Study ID Numbers: 10381
Study First Received: January 8, 2010
Last Updated: January 8, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:
Pulmonary Abscess
Aspiration Pneumonia

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

ClinicalTrials.gov processed this record on May 19, 2013