Outcomes of Patients Not Responding to Antibiotics in the Community

NCT00245427 | Completed

• 1 other identifier: HMR3647A-6012
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sinusitis; Bronchitis, Chronic; Pneumonia, Bacterial

Keywords

beta-lactam; macrolide; antibiotics

Outcome Measures

Primary Outcomes (1)

• Clinical outcome

  varies

Secondary Outcomes (1)

• PK/PD pharmacoeconomics

  varies

Study Arms (2)

1 All macrolide antibiotics

OTHER

Drug: all macrolide antibiotics

2 All beta lactam antibiotics

OTHER

Drug: all beta-lactam antibiotics

Interventions

all macrolide antibiotics DRUG

Varies based on antibiotic

1 All macrolide antibiotics

all beta-lactam antibiotics DRUG

Varies based on antibiotic

2 All beta lactam antibiotics

Eligibility Criteria

• Age: Up to 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• CPL Associates: lead
• Sanofi: collaborator

Study Sites (1)

Deaconess Medical School

Spokane, Washington, 99204, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Sinusitis; Bronchitis, Chronic; Pneumonia, Bacterial

Condition Hierarchy (Ancestors)

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

Study Officials

• Jerome J Schentag, Pharm.D.

  State University of NY at Buffalo

  PRINCIPAL INVESTIGATOR

• Joseph Paladino, Pharm.D.

  State University of NY at Buffalo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 26, 2005
• First Posted: October 28, 2005
• Study Start: December 1, 2005
• Study Completion: March 1, 2006
• Last Updated: October 31, 2007

Record last verified: 2007-10

Locations

US (1)