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| Sponsors and Collaborators: |
CPL Associates Sanofi-Aventis |
|---|---|
| Information provided by: | CPL Associates |
| ClinicalTrials.gov Identifier: | NCT00245427 |
Purpose
A study to report the outcomes of patients who fail to respond to beta-lactam and macrolide antibiotics in the community
| Condition | Intervention |
|---|---|
|
Sinusitis Bronchitis, Chronic Pneumonia, Bacterial |
Drug: all macrolide antibiotics Drug: all beta-lactam antibiotics |
| Study Type: | Interventional |
| Study Design: | Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| 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 |
| Enrollment: | 200 |
| Study Start Date: | December 2005 |
| Study Completion Date: | March 2006 |
| Arms | Assigned Interventions |
|---|---|
| 1 All macrolide antibiotics |
Drug: all macrolide antibiotics
Varies based on antibiotic
|
| 2 All beta lactam antibiotics |
Drug: all beta-lactam antibiotics
Varies based on antibiotic
|
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
Eligibility| Ages Eligible for Study: | up to 95 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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:
Contacts and Locations| United States, Washington | |
| Deaconess Medical School | |
| Spokane, Washington, United States, 99204 | |
| 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 |
More Information
| Study ID Numbers: | HMR3647A-6012 |
| Study First Received: | October 26, 2005 |
| Last Updated: | October 29, 2007 |
| ClinicalTrials.gov Identifier: | NCT00245427 |
| Health Authority: | United States: Food and Drug Administration |
|
beta-lactam macrolide antibiotics |
|
Bacterial Infections Lactams Otorhinolaryngologic Diseases Sinusitis Bronchitis, Chronic Lung Diseases, Obstructive Respiratory Tract Diseases |
Respiratory Tract Infections Pneumonia, Bacterial Lung Diseases Beta-Lactams Bronchitis Pneumonia Pulmonary Disease, Chronic Obstructive |
|
Anti-Infective Agents Anti-Bacterial Agents Bronchial Diseases Paranasal Sinus Diseases |
Therapeutic Uses Pharmacologic Actions Nose Diseases |
