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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
A study to report the outcomes of patients who fail to respond to beta-lactam and macrolide antibiotics in the community
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 All macrolide antibiotics | Other |
| |
| 2 All beta lactam antibiotics | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| all macrolide antibiotics | Drug | Varies based on antibiotic |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical outcome | varies |
| Measure | Description | Time Frame |
|---|---|---|
| PK/PD pharmacoeconomics | varies |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Jerome J Schentag, Pharm.D. | State University of NY at Buffalo | Principal Investigator |
| Joseph Paladino, Pharm.D. | State University of NY at Buffalo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Deaconess Medical School | Spokane | Washington | 99204 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D012852 | Sinusitis |
| D029481 | Bronchitis, Chronic |
| D018410 | Pneumonia, Bacterial |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010254 | Paranasal Sinus Diseases |
| D009668 | Nose Diseases |
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| all beta-lactam antibiotics |
| Drug |
Varies based on antibiotic |
|
| D012140 |
| Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D011014 | Pneumonia |