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NCT00245427 Clinical Trial

Outcomes of Patients Not Responding to Antibiotics in the Community

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00245427
Other study ID # HMR3647A-6012
Secondary ID
Status Completed
Phase N/A
First received October 26, 2005
Last updated October 29, 2007
Start date December 2005
Est. completion date March 2006

Study information
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

Clinical Trial Summary

A study to report the outcomes of patients who fail to respond to beta-lactam and macrolide antibiotics in the community

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 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

Recruitment information / eligibility
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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Drug:
• all macrolide antibiotics
Varies based on antibiotic
• all beta-lactam antibiotics
Varies based on antibiotic

Locations
Country Name City State
United States Deaconess Medical School Spokane Washington

Sponsors (2)
Lead Sponsor Collaborator
CPL Associates Sanofi

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical outcome varies
Secondary PK/PD pharmacoeconomics varies
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