Trial Condition(s):
Pneumonia, Aspiration, Lung Abscess
BAY12-8039, iv/oral Pulmonary Abscess/Aspiration Pneumonia
Bayer Identifier:
10381
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial 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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Helios Klinikum Emil von Behring Berlin, Germany, 14165 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum Lüdenscheid- Untern.verb. Märkische Kliniken GmbH Lüdenscheid, Germany, 58515 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kliniken Nord und Süd Nürnberg, Germany, 90419 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Diakoniekrankenhaus Rotenburg, Germany, 27356 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Schleswig-Holstein Lübeck, Germany, 23538 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Otto-von Guericke - Magdeburg Magdeburg, Germany, 39112 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum der Universität Regensburg Regensburg, Germany, 93053 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Charité Campus Virchow-Klinikum (CVK) Berlin, Germany, 13353 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Brüderkrankenhaus St. Josef Paderborn, Germany, 33098 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St. Josef-Hospital Oberhausen, Germany, 46045 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Johanniter-Krankenhaus in Fläming gGmbH Treuenbrietzen, Germany, 14929 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum Mannheim gGmbH Mannheim, Germany, 68167 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Städt. Krankenhaus Hildesheim GmbH Hildesheim, Germany, 31134 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum der Johann Wolfgang Goethe Universität Frankfurt, Germany, 60596 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Städtisches Klinikum "St. Georg" Leipzig Leipzig, Germany, 04129 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Adverse events occuring after first application of study medication up to the test of cure visit for non-serious adverse eventsTimeframe: Up to 30 days after end of treatment with study medication for serious adverse events
Secondary Outcome
- Clinical ResponseTimeframe: Regulary doing i.v. treatment
Additional Information
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