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Outcomes of Patients Not Responding to Antibiotics in the Community

This study has been completed.
Information provided by:
CPL Associates Identifier:
First received: October 26, 2005
Last updated: October 29, 2007
Last verified: October 2007
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
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

Resource links provided by NLM:

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

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

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
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Please refer to this study by its identifier: NCT00245427

United States, Washington
Deaconess Medical School
Spokane, Washington, United States, 99204
Sponsors and Collaborators
CPL Associates
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: Identifier: NCT00245427     History of Changes
Other Study ID Numbers: HMR3647A-6012
Study First Received: October 26, 2005
Last Updated: October 29, 2007

Keywords provided by CPL Associates:

Additional relevant MeSH terms:
Pneumonia, Bacterial
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
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents processed this record on August 21, 2017