Trials Sponsors Conditions Drugs Pricing

Conditions

Bronchitis, Chronic Pneumonia, Bacterial Sinusitis

Keywords

beta-lactammacrolideantibiotics

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 antibioticsDrug

Varies based on antibiotic

1 All macrolide antibiotics

all beta-lactam antibioticsDrug

Varies based on antibiotic

2 All beta lactam antibiotics

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

AgeUp to 95 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (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.

Sponsors & Collaborators

CPL Associates
Otherlead
Sanofi
Industrycollaborator

Study Sites (1)

Deaconess Medical School

Spokane, Washington, 99204, United States

MeSH Terms

Conditions

SinusitisBronchitis, ChronicPneumonia, Bacterial

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesBronchitisBronchial DiseasesLung Diseases, ObstructiveLung DiseasesPulmonary Disease, Chronic ObstructiveChronic Disease

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

Enrollment

200 participants (actual enrollment reported by the registry).

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 2005

Date type not reported

This date has not been verified as actual or estimated.

Outcomes of Patients Not Responding to Antibiotics in the Community

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

1 All macrolide antibiotics

2 All beta lactam antibiotics

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

1 All macrolide antibiotics

2 All beta lactam antibiotics

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations