- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00786513
Use of a Biofilm Antimicrobial Susceptibility Assay to Guide Antibiotic Therapy
April 2, 2014 updated by: Valerie Waters, The Hospital for Sick Children
Randomized Double Blind Controlled Trial of the Use of a Biofilm Antimicrobial Susceptibility Assay to Guide Antibiotic Therapy in Chronic Pseudomonas Aeruginosa Infected Cystic Fibrosis Patients
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 treat CF patients with chronic P. aeruginosa infection with an acute pulmonary exacerbation is a safe intervention that will result in improved microbiological and clinical outcomes and decrease markers of pulmonary inflammation.
Study Overview
Status
Completed
Conditions
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 cause of death in CF patients.
The improved life expectancy of CF patients in the past several decades is due in part to the more aggressive use of antibiotics in the treatment of respiratory infections.
However, there is currently no antimicrobial susceptibility assay that can predict which antibiotics will result in improved patient outcomes.
Since Pseudomonas aeruginosa is known to grow as a resistant biofilm in the CF lung, antimicrobial susceptibility testing based on biofilm growth of P. aeruginosa may lead to different antibiotic choices that significantly decrease the pulmonary bacterial density of P. aeruginosa.
A biofilm antimicrobial susceptibility assay thus has the ability to change the way antibiotics are chosen to treat CF patients and result in improved lung function and longer lives for all CF patients.
Study Type
Interventional
Enrollment (Actual)
134
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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British Columbia
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Vancouver, British Columbia, Canada
- BC Children's Hospital
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Vancouver, British Columbia, Canada
- St. Paul's Hospital
-
-
Ontario
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Hamilton, Ontario, Canada
- Hamilton Health Sciences
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Toronto, Ontario, Canada
- St. Michael's Hospital
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Toronto, Ontario, Canada
- The Hospital for Sick Children
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Arm
|
Subjects in this arm will be prescribed 14 days of an intravenous 2 drug antibiotic combination based on biofilm antimicrobial susceptibility testing results.
|
Active Comparator: Control Arm
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Subjects in this arm will be prescribed 14 days of an intravenous 2 drug antibiotic combination based on conventional planktonic antimicrobial susceptibility testing results.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The proportion of patients in the intervention arm versus the control arm who have ≥ 3 log drop in colony forming units (CFUs) of P. aeruginosa in sputum.
Time Frame: Measured at day 0 and day 14 of antibiotic treatment and at the 1 month follow-up visit
|
Measured at day 0 and day 14 of antibiotic treatment and at the 1 month follow-up visit
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The change in pulmonary function tests, including forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), and maximal midexpiratory flow rate (FEF25-75) in the intervention arm versus the control arm
Time Frame: Measured at day 0, day 7, and day 14 of antibiotic treatment and at the 1 month follow-up visit
|
Measured at day 0, day 7, and day 14 of antibiotic treatment and at the 1 month follow-up visit
|
The time to subsequent acute pulmonary exacerbation in the intervention arm versus the control arm
Time Frame: 1 year following the completion of antibiotic therapy
|
1 year following the completion of antibiotic therapy
|
The change in the cumulative score on a quality of life questionnaire in the intervention arm versus the control arm
Time Frame: Measued at day 0 and day 14 of antibiotic treatment and at the 1 month follow-up visit
|
Measued at day 0 and day 14 of antibiotic treatment and at the 1 month follow-up visit
|
The change in the measurement of markers of pulmonary inflammation (neutrophil counts, neutrophil elastase and IL-8 levels in sputum) in the intervention arm versus the control arm.
Time Frame: Meaured at day 0 and day 14 of antibiotic treatment and at the 1 month follow-up visit
|
Meaured at day 0 and day 14 of antibiotic treatment and at the 1 month follow-up visit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Valerie Waters, MD, The Hospital for Sick Children
- Principal Investigator: Yvonne Yau, MD, The Hospital for Sick Children
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2008
Primary Completion (Actual)
March 1, 2014
Study Completion (Actual)
March 1, 2014
Study Registration Dates
First Submitted
November 5, 2008
First Submitted That Met QC Criteria
November 5, 2008
First Posted (Estimate)
November 6, 2008
Study Record Updates
Last Update Posted (Estimate)
April 4, 2014
Last Update Submitted That Met QC Criteria
April 2, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1000011132
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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