Overview
Outcomes of Patients Not Responding to Antibiotics in the Community
Status:
Completed
Completed
Trial end date:
2006-03-01
2006-03-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
A study to report the outcomes of patients who fail to respond to beta-lactam and macrolide antibiotics in the communityPhase:
N/AAccepts Healthy Volunteers?
NoDetails
Lead Sponsor:
CPL AssociatesCollaborator:
SanofiTreatments:
Anti-Bacterial Agents
Antibiotics, Antitubercular
beta-Lactams
Lactams
Criteria
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