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Completed

NCT Number: NCT01045902

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

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.

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Key information

Conditions

Pneumonia, Aspiration Abscess Infections Lung Abscess Lung Diseases Pneumonia Respiratory Tract Diseases Respiratory Tract Infections Suppuration

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mannheim, Baden-Wurttemberg, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Avelox (Moxifloxacin, BAY12-8039)

Drug

Moxifloxacin, 400 mg iv, od, switch after 6 doses (6 days) to 400 mg Moxifloxacin oral, od

Sulbactam/Ampicillin

Drug

Sulbactam/Ampicillin, 3 g iv, tid, switch after 18 doses (6 days) to 750 mg Sulbactam/Ampicillin oral, bid

Primary outcomes

  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 outcomes

  1. Clinical Response

    Time frame: Regulary doing i.v. treatment

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2001
Study completion
2005
First posted
Jan 11, 2010
Registry last updated
Jan 11, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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