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Sponsored by: |
The Hospital for Sick Children |
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Information provided by: | The Hospital for Sick Children |
ClinicalTrials.gov Identifier: | NCT00786513 |
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.
Condition | Intervention | Phase |
---|---|---|
Cystic Fibrosis |
Other: Conventional antimicrobial susceptibility testing Other: Biofilm antimicrobial susceptibility testing |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 200 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | May 2012 |
Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Control Arm: Active Comparator |
Other: Conventional antimicrobial susceptibility testing
Subjects in this arm will be prescribed 14 days of an intravenous 2 drug antibiotic combination based on conventional planktonic antimicrobial susceptibility testing results.
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Intervention Arm: Experimental |
Other: Biofilm antimicrobial susceptibility testing
Subjects in this arm will be prescribed 14 days of an intravenous 2 drug antibiotic combination based on biofilm antimicrobial susceptibility testing results.
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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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, Ontario | |
The Hospital for Sick Children | Recruiting |
Toronto, Ontario, Canada | |
Contact: Valerie Waters, MD (416)813-7654 ext 4541 valerie.waters@sickkids.ca | |
Principal Investigator: Valerie Waters, MD | |
Principal Investigator: Yvonne Yau, MD | |
Sub-Investigator: Felix Ratjen, MD | |
Sub-Investigator: Elizabeth Tullis, MD |
Principal Investigator: | Valerie Waters, MD | The Hospital for Sick Children |
Principal Investigator: | Yvonne Yau, MD | The Hospital for Sick Children |
Responsible Party: | The Hospital for Sick Children ( Valerie Waters/Principal Investigator ) |
Study ID Numbers: | 1000011132 |
Study First Received: | November 5, 2008 |
Last Updated: | November 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00786513 History of Changes |
Health Authority: | Canada: Ethics Review Committee |
Cystic fibrosis Pseudomonas aeruginosa biofilm antibiotic susceptibility testing pediatrics |
Anti-Bacterial Agents Digestive System Diseases Genetic Diseases, Inborn Respiratory Tract Diseases Disease Susceptibility Cystic Fibrosis |
Fibrosis Lung Diseases Infant, Newborn, Diseases Pancreatic Diseases Genetic Predisposition to Disease |
Anti-Infective Agents Disease Attributes Disease Susceptibility Fibrosis Pharmacologic Actions Anti-Bacterial Agents Digestive System Diseases Pathologic Processes |
Cystic Fibrosis Respiratory Tract Diseases Genetic Diseases, Inborn Therapeutic Uses Lung Diseases Pancreatic Diseases Infant, Newborn, Diseases Genetic Predisposition to Disease |