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OpenTrials
Completed

NCT Number: NCT00245427

Outcomes of Patients Not Responding to Antibiotics in the Community

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

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Key information

Conditions

Sinusitis Bacterial Infections Bacterial Infections and Mycoses Bronchial Diseases Bronchitis Bronchitis, Chronic Chronic Disease Disease Attributes Infections Lung Diseases Lung Diseases, Obstructive Nose Diseases Otorhinolaryngologic Diseases Paranasal Sinus Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Bacterial Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Respiratory Tract Infections

Age range

Up to 95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Deaconess Medical School

Spokane, Washington, 99204, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • Life expectancy <3 months from underlying disease
  • Underlying lung carcinoma
  • Cystic fibrosis

Treatment and study plan

all macrolide antibiotics

Drug

Varies based on antibiotic

all beta-lactam antibiotics

Drug

Varies based on antibiotic

Primary outcomes

  1. Clinical outcome

    Time frame: varies

Secondary outcomes

  1. PK/PD pharmacoeconomics

    Time frame: varies

Sponsors and collaborators

Lead sponsor

CPL Associates

Other

Collaborators

  • Sanofi

Registry information

Official study 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

Important dates

Study start
2005
Study completion
2006
First posted
Oct 28, 2005
Registry last updated
Oct 31, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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