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Outcomes of Patients Not Responding to Antibiotics in the Community

C

CPL Associates

Status

Completed

Conditions

Bronchitis, Chronic
Pneumonia, Bacterial
Sinusitis

Treatments

Drug: all macrolide antibiotics
Drug: all beta-lactam antibiotics

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00245427
HMR3647A-6012

Details and patient eligibility

About

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

Full 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

Enrollment

200 patients

Sex

All

Ages

Under 95 years old

Volunteers

No Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

1 All macrolide antibiotics
Other group
Treatment:
Drug: all macrolide antibiotics
2 All beta lactam antibiotics
Other group
Treatment:
Drug: all beta-lactam antibiotics

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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