Use of a Biofilm Antimicrobial Susceptibility Assay to Guide Antibiotic Therapy
This study is currently recruiting participants.
Verified October 2011 by The Hospital for Sick Children
Sponsor:
The Hospital for Sick Children
Information provided by:
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00786513
First received: November 5, 2008
Last updated: October 27, 2011
Last verified: October 2011
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Purpose
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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by The Hospital for Sick Children:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| 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 |
|---|---|
| Active Comparator: Control Arm |
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.
|
| Experimental: Intervention Arm |
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.
|
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00786513
Contacts
| Contact: Valerie Waters, MD | 416-813-7654 ext 4541 | valerie.waters@sickkids.ca |
Locations
| Canada, British Columbia | |
| St. Paul's Hospital | Recruiting |
| Vancouver, British Columbia, Canada | |
| Principal Investigator: Pearce Wilcox, MD | |
| BC Children's Hospital | Recruiting |
| Vancouver, British Columbia, Canada | |
| Principal Investigator: Mark Chilvers, MD | |
| Canada, Ontario | |
| Hamilton Health Sciences | Recruiting |
| Hamilton, Ontario, Canada | |
| Principal Investigator: Andreas Frietag, MD | |
| 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 | |
| St. Michael's Hospital | Recruiting |
| Toronto, Ontario, Canada | |
| Principal Investigator: Elizabeth Tullis, MD | |
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
| Principal Investigator: | Valerie Waters, MD | The Hospital for Sick Children |
| Principal Investigator: | Yvonne Yau, MD | The Hospital for Sick Children |
More Information
No publications provided
| Responsible Party: | Valerie Waters/Principal Investigator, The Hospital for Sick Children |
| ClinicalTrials.gov Identifier: | NCT00786513 History of Changes |
| Other Study ID Numbers: | 1000011132 |
| Study First Received: | November 5, 2008 |
| Last Updated: | October 27, 2011 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by The Hospital for Sick Children:
|
Cystic fibrosis Pseudomonas aeruginosa biofilm antibiotic susceptibility testing pediatrics |
Additional relevant MeSH terms:
|
Cystic Fibrosis Disease Susceptibility Genetic Predisposition to Disease Fibrosis Pancreatic Diseases Digestive System Diseases Lung Diseases Respiratory Tract Diseases |
Genetic Diseases, Inborn Infant, Newborn, Diseases Disease Attributes Pathologic Processes Anti-Infective Agents Anti-Bacterial Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013