Outcomes of Patients Not Responding to Antibiotics in the Community

Not Applicable

Completed

• Conditions: Sinusitis; Bronchitis, Chronic; Pneumonia, Bacterial
• Interventions: Drug: all macrolide antibiotics; Drug: all beta-lactam antibiotics

• Registration Number: NCT00245427
• Lead Sponsor: CPL Associates

Brief Summary

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

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 Timeline

• Study First Submitted: 2005-10-26
• Study First Submitted QC: 2005-10-26
• Study First Posted: 2005-10-28
• Study Start: 2005-12
• Study Completion: 2006-03
• Status Verified: 2007-10
• Last Update Submitted: 2007-10-29
• Last Update Posted: 2007-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 All macrolide antibiotics	all macrolide antibiotics	-
2 All beta lactam antibiotics	all beta-lactam antibiotics	-

Primary Outcome Measures

Name	Time	Method
Clinical outcome	varies

Secondary Outcome Measures

Name	Time	Method
PK/PD pharmacoeconomics	varies

Trial Locations

Locations (1)

Deaconess Medical School; 🇺🇸 Spokane, Washington, United States