check_circleStudy Completed

Pneumonia, Aspiration, Lung Abscess

Bayer Identifier:

10381

ClinicalTrials.gov Identifier:

NCT01045902

EudraCT Number:

Not Available

EU CT Number:

Not Available
BAY12-8039, iv/oral Pulmonary Abscess/Aspiration Pneumonia

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.

Key Participants Requirements

Sex

Both

Age

18 Years
  • - 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
  • - 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
139
Trial Dates
February 2001 - January 2005
Phase
Phase 3
Could I Receive a placebo
No
Products
Avelox (Moxifloxacin hydrochloride, BAY12-8039)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Helios Klinikum Emil von BehringBerlin, 14165, Germany
Completed
Klinikum Lüdenscheid- Untern.verb. Märkische Kliniken GmbHLüdenscheid, 58515, Germany
Completed
Kliniken Nord und SüdNürnberg, 90419, Germany
Completed
DiakoniekrankenhausRotenburg, 27356, Germany
Completed
Universitätsklinikum Schleswig-HolsteinLübeck, 23538, Germany
Completed
Universitätsklinikum Otto-von Guericke - MagdeburgMagdeburg, 39112, Germany
Completed
Klinikum der Universität RegensburgRegensburg, 93053, Germany
Completed
Charité Campus Virchow-Klinikum (CVK)Berlin, 13353, Germany
Completed
Brüderkrankenhaus St. JosefPaderborn, 33098, Germany
Completed
St. Josef-HospitalOberhausen, 46045, Germany
Completed
Johanniter-Krankenhaus in Fläming gGmbHTreuenbrietzen, 14929, Germany
Completed
Klinikum Mannheim gGmbHMannheim, 68167, Germany
Completed
Städt. Krankenhaus Hildesheim GmbHHildesheim, 31134, Germany
Completed
Klinikum der Johann Wolfgang Goethe UniversitätFrankfurt, 60596, Germany
Completed
Städtisches Klinikum "St. Georg" LeipzigLeipzig, 04129, Germany

Primary Outcome

  • Adverse events occuring after first application of study medication up to the test of cure visit for non-serious adverse events
    date_rangeTime Frame:
    Up to 30 days after end of treatment with study medication for serious adverse events
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Clinical Response
    date_rangeTime Frame:
    Regulary doing i.v. treatment
    enhanced_encryption
    Safety Issue:
    no

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

Additional Information

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