Sinusitis Clinical Trial
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
Verified date | October 2007 |
Source | CPL Associates |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
A study to report the outcomes of patients who fail to respond to beta-lactam and macrolide antibiotics in the community
Status | Completed |
Enrollment | 200 |
Est. completion date | March 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 95 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
United States | Deaconess Medical School | Spokane | Washington |
Lead Sponsor | Collaborator |
---|---|
CPL Associates | Sanofi |
United States,
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---|---|---|---|---|
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