BAY12-8039, iv/Oral Pulmonary Abscess/Aspiration Pneumonia | NCT01045902

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

NCT01045902

Sponsor

Bayer

Status

Completed

Last Update Posted

Jan 11, 2010Estimated

Enrollment

139Actual

Phase

Phase 3

Conditions

Pneumonia, Aspiration
Lung Abscess

Interventions

Avelox (Moxifloxacin, BAY12-8039)
Sulbactam/Ampicillin

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2001

Primary Completion Date

Not provided

Completion Date

Jan 2005Actual

First Submitted Date

Jan 8, 2010

First Submission Date that Met QC Criteria

Jan 8, 2010

First Posted Date

Jan 11, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 8, 2010

Last Update Posted Date

Jan 11, 2010Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

139Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Experimental		Drug: Avelox (Moxifloxacin, BAY12-8039)
Arm 2	Active Comparator		Drug: Sulbactam/Ampicillin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Avelox (Moxifloxacin, BAY12-8039)	Drug	Moxifloxacin, 400 mg iv, od, switch after 6 doses (6 days) to 400 mg Moxifloxacin oral, od	Arm 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse events occuring after first application of study medication up to the test of cure visit for non-serious adverse events		Up to 30 days after end of treatment with study medication for serious adverse events

Secondary Outcomes

Measure	Description	Time Frame
Clinical Response		Regulary doing i.v. treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Mannheim	Baden-Wurttemberg	68167	Germany

Condition Browse Module

MeSH Terms

ID	Term
D011015	Pneumonia, Aspiration
D008169	Lung Abscess

Ancestor Terms

ID	Term
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077266	Moxifloxacin
C035444	sultamicillin

Ancestor Terms

ID	Term
D024841	Fluoroquinolones
D042462	4-Quinolones
D015363	Quinolones
D011804	Quinolines

Browse Leaves

Not provided

Browse Branches

Not provided