Status:
COMPLETED
Use of a Biofilm Antimicrobial Susceptibility Assay to Guide Antibiotic Therapy
Lead Sponsor:
The Hospital for Sick Children
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether choosing antibiotics based on a biofilm antimicrobial susceptibility assay rather than a conventional planktonic antimicrobial susceptibility assay to...
Detailed Description
Cystic fibrosis (CF) is the most common fatal genetic condition in the Caucasian population and affects over 3,000 Canadians. Respiratory failure caused by chronic pulmonary infection is the primary c...
Eligibility Criteria
Inclusion
- Diagnosis of CF based on the following: sweat chloride \> 60 mEq/L or genotype with 2 identifiable mutations consistent with CF; and one or more clinical features consistent with CF
- Chronically infected with P. aeruginosa (\>50% of respiratory specimens positive for P. aeruginosa in the 24 months prior to screening)
- Able to produce sputum (expectorated or induced)
- Able to reproducibility perform pulmonary function testing
- Written informed consent provided
Exclusion
- Sputum culture negative for P. aeruginosa or with a density of less that 10\^5 CFU/g at screening
- Sputum culture positive for Burkholderia cepacia at screening
- History of B. cepacia positive respiratory culture within 24 months prior to screening
- Use of antibiotics other than those prescribed by the principal investigator
- History of allergy (urticarial rash, diffuse erythroderma, serum sickness) to more than two groups of antibiotics (aminoglycosides, penicillins, cephalosporins, monobactams, macrolides, or quinolones) that are a therapeutic option
- History of anaphylaxis or other life threatening complication to any antibiotic in the six groups that are a therapeutic option
- Post lung transplantation or listed for lung transplantation
- Pregnancy
- A septic or clinically unstable patient
- Presence of a condition or abnormality that in the opinion of an investigator would compromise the safety of the patient or the quality of the data
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT00786513
Start Date
November 1 2008
End Date
March 1 2014
Last Update
April 4 2014
Active Locations (5)
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1
BC Children's Hospital
Vancouver, British Columbia, Canada
2
St. Paul's Hospital
Vancouver, British Columbia, Canada
3
Hamilton Health Sciences
Hamilton, Ontario, Canada
4
St. Michael's Hospital
Toronto, Ontario, Canada