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Outcomes of Patients Not Responding to Antibiotics in the Community

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ClinicalTrials.gov Identifier: NCT00245427
Recruitment Status : Completed
First Posted : October 28, 2005
Last Update Posted : October 31, 2007
Sponsor:
Collaborator:
Sanofi
Information provided by:
CPL Associates

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

Condition or disease Intervention/treatment
Sinusitis Bronchitis, Chronic Pneumonia, Bacterial Drug: all macrolide antibiotics Drug: all beta-lactam antibiotics

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 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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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
Study Start Date : December 2005
Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Clinical outcome [ Time Frame: varies ]

Secondary Outcome Measures :
  1. PK/PD pharmacoeconomics [ Time Frame: varies ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 95 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00245427


Locations
United States, Washington
Deaconess Medical School
Spokane, Washington, United States, 99204
Sponsors and Collaborators
CPL Associates
Sanofi
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

Additional Information:
ClinicalTrials.gov Identifier: NCT00245427     History of Changes
Other Study ID Numbers: HMR3647A-6012
First Posted: October 28, 2005    Key Record Dates
Last Update Posted: October 31, 2007
Last Verified: October 2007

Keywords provided by CPL Associates:
beta-lactam
macrolide
antibiotics

Additional relevant MeSH terms:
Pneumonia, Bacterial
Pneumonia
Bronchitis
Sinusitis
Bronchitis, Chronic
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Bronchial Diseases
Lung Diseases, Obstructive
Paranasal Sinus Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Bacterial Infections
Pulmonary Disease, Chronic Obstructive
Anti-Bacterial Agents
Lactams
beta-Lactams
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents