Outcomes of Patients Not Responding to Antibiotics in the Community

Sponsor

CPL Associates (Other)

Overall Status

Completed

CT.gov ID

NCT00245427

Collaborator

Sanofi (Industry)

200

Enrollment

Location

Arms

Duration (Months)

67.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Sinusitis Bronchitis, Chronic Pneumonia, Bacterial	Drug: all macrolide antibiotics Drug: all beta-lactam antibiotics	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Official Title:

Outcomes of Patients Not Responding to Outpatient Macrolide or b-Lactam Therapy for the Treatment of Community Acquired Pneumonia: Expansion to Include Acute Exacerbations of Chronic Bronchitis and Acute Sinusitis

Study Start Date :

Dec 1, 2005

Actual Study Completion Date :

Mar 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Other: 1 All macrolide antibiotics	Drug: all macrolide antibiotics Varies based on antibiotic
Other: 2 All beta lactam antibiotics	Drug: all beta-lactam antibiotics Varies based on antibiotic

Arm

Intervention/Treatment

Other: 1 All macrolide antibiotics

Drug: all macrolide antibiotics

Varies based on antibiotic

Other: 2 All beta lactam antibiotics

Drug: all beta-lactam antibiotics

Varies based on antibiotic

Outcome Measures

Primary Outcome Measures

Clinical outcome [varies]

Secondary Outcome Measures

PK/PD pharmacoeconomics [varies]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 95 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

Life expectancy <3 months from underlying disease
Underlying lung carcinoma
Cystic fibrosis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Deaconess Medical School	Spokane	Washington	United States	99204

Sponsors and Collaborators

CPL Associates
Sanofi

Investigators

Principal Investigator: Jerome J Schentag, Pharm.D., State University of NY at Buffalo
Study Director: Joseph Paladino, Pharm.D., State University of NY at Buffalo