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Outcomes of Patients Not Responding to Antibiotics in the Community

NCT ID: NCT00245427

Last Updated: 2007-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2006-03-31

Brief Summary

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A study to report the outcomes of patients who fail to respond to beta-lactam and macrolide antibiotics in the community

Detailed Description

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To document and describe the clinical, microbiological, and pharmacoeconomic outcomes of two hundred patients who failed to respond to outpatient macrolide or beta-lactam therapy. Evaluable patients must have a positive culture obtained after they failed their initial macrolide or beta-lactam. The isolated pathogen must have a known MIC to the antibiotic class they failed to respond to (i.e. macrolide or b-lactam). The isolate must be available to be sent to the central laboratory for MIC testing

Conditions

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Sinusitis Bronchitis, Chronic Pneumonia, Bacterial

Keywords

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beta-lactam macrolide antibiotics

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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1 All macrolide antibiotics

Group Type OTHER

all macrolide antibiotics

Intervention Type DRUG

Varies based on antibiotic

2 All beta lactam antibiotics

Group Type OTHER

all beta-lactam antibiotics

Intervention Type DRUG

Varies based on antibiotic

Interventions

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all macrolide antibiotics

Varies based on antibiotic

Intervention Type DRUG

all beta-lactam antibiotics

Varies based on antibiotic

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Patients who have failed to respond to at least three (ABECB and CAP) or five (AMS/ABRS/AECRS) days of macrolide or b-lactam therapy meeting all of the protocol criteria for acute bacterial exacerbations on chronic bronchitis(ABECB), community acquired pneumonia(CAP) and acute maxillary sinusitis(AMS) will be eligible for enrollment. All patients, whether enrolled retrospectively or concurrently, must have a positive culture. The pathogenic bacteria must be identified by a local laboratory and have a known susceptibility to the antibiotic class the patient failed to respond to (i.e. macrolide or b-lactam). The isolate must be sent to the Study Coordinating Center for precise MIC determination.

Exclusion Criteria

Patients presenting with any of the following will not be included in the study:

1. Life expectancy \<3 months from underlying disease
2. Underlying lung carcinoma
3. Cystic fibrosis
Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role collaborator

CPL Associates

OTHER

Sponsor Role lead

Principal Investigators

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Jerome J Schentag, Pharm.D.

Role: PRINCIPAL_INVESTIGATOR

State University of NY at Buffalo

Joseph Paladino, Pharm.D.

Role: STUDY_DIRECTOR

State University of NY at Buffalo

Locations

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Deaconess Medical School

Spokane, Washington, United States

Site Status

Countries

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United States

Related Links

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http://www.cplassociates.com

Related Info

Other Identifiers

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HMR3647A-6012

Identifier Type: -

Identifier Source: org_study_id