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Outcomes of Patients Not Responding to Antibiotics in the Community

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by:
CPL Associates
ClinicalTrials.gov Identifier:
NCT00245427
First received: October 26, 2005
Last updated: October 29, 2007
Last verified: October 2007
History of Changes
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by CPL Associates:

Primary Outcome Measures:
  • Clinical outcome [ Time Frame: varies ]

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

Enrollment: 200
Study Start Date: December 2005
Study Completion Date: March 2006
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   up to 95 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00245427     History of Changes
Other Study ID Numbers: HMR3647A-6012
Study First Received: October 26, 2005
Last Updated: October 29, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by CPL Associates:
beta-lactam
macrolide
antibiotics

Additional relevant MeSH terms:
Pneumonia, Bacterial
Bronchitis
Acute Disease
Bronchitis, Chronic
Pneumonia
Sinusitis
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Bronchial Diseases
Lung Diseases, Obstructive
 Disease Attributes
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Paranasal Sinus Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Anti-Bacterial Agents
Lactams
Beta-Lactams
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013