Status:
COMPLETED
Outcomes of Patients Not Responding to Antibiotics in the Community
Lead Sponsor:
CPL Associates
Collaborating Sponsors:
Sanofi
Conditions:
Sinusitis
Bronchitis, Chronic
Eligibility:
All Genders
Up to 95 years
Phase:
NA
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 m...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2006
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00245427
Start Date
December 1 2005
End Date
March 1 2006
Last Update
October 31 2007
Active Locations (1)
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1
Deaconess Medical School
Spokane, Washington, United States, 99204