Outcomes of Patients Not Responding to Antibiotics in the Community

Study Overview
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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

Official Title
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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

Conditions
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Sinusitis, Bronchitis, Chronic, Pneumonia, Bacterial

Intervention / Treatment
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* Drug: all macrolide antibiotics
* Drug: all beta-lactam antibiotics


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

Ages Eligible for Study
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Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1 All macrolide antibiotics<br> | Drug: all macrolide antibiotics<br>* Varies based on antibiotic<br>|
| Other: 2 All beta lactam antibiotics<br> | Drug: all beta-lactam antibiotics<br>* Varies based on antibiotic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcome |  | varies | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK/PD pharmacoeconomics |  | varies | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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beta-lactam, macrolide, antibiotics