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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00245427

Enrollment

200

Registered

2005-10-28

Start date

2005-12-31

Completion date

2006-03-31

Last updated

2007-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchitis, Chronic, Pneumonia, Bacterial, Sinusitis

Keywords

beta-lactam, macrolide, antibiotics

Brief summary

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

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

Interventions

DRUGall macrolide antibiotics

Varies based on antibiotic

DRUGall beta-lactam antibiotics

Varies based on antibiotic

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 95 Years

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

Design outcomes

Primary

Measure	Time frame
Clinical outcome	varies

Secondary

Measure	Time frame
PK/PD pharmacoeconomics	varies

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026