- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00245427
Outcomes of Patients Not Responding to Antibiotics in the Community
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Washington
-
Spokane, Washington, United States, 99204
- Deaconess Medical School
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- Life expectancy <3 months from underlying disease
- Underlying lung carcinoma
- Cystic fibrosis
Study Plan
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 1 All macrolide antibiotics
|
Varies based on antibiotic
|
Other: 2 All beta lactam antibiotics
|
Varies based on antibiotic
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Clinical outcome
Time Frame: varies
|
varies
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
PK/PD pharmacoeconomics
Time Frame: varies
|
varies
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- 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
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Lung Diseases
- Bronchial Diseases
- Otorhinolaryngologic Diseases
- Bacterial Infections
- Bacterial Infections and Mycoses
- Lung Diseases, Obstructive
- Pulmonary Disease, Chronic Obstructive
- Paranasal Sinus Diseases
- Nose Diseases
- Pneumonia
- Sinusitis
- Pneumonia, Bacterial
- Bronchitis
- Bronchitis, Chronic
- Anti-Infective Agents
- Antitubercular Agents
- Anti-Bacterial Agents
- Antibiotics, Antitubercular
- Lactams
- beta-Lactams
Other Study ID Numbers
- HMR3647A-6012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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