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Use of a Biofilm Antimicrobial Susceptibility Assay to Guide Antibiotic Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Valerie Waters, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00786513
First received: November 5, 2008
Last updated: April 2, 2014
Last verified: April 2014

November 5, 2008
April 2, 2014
November 2008
March 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00786513 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Use of a Biofilm Antimicrobial Susceptibility Assay to Guide Antibiotic Therapy
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Cystic Fibrosis
  • 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.
  • 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.
  • Active Comparator: Control Arm
    Intervention: Other: Conventional antimicrobial susceptibility testing
  • Experimental: Intervention Arm
    Intervention: Other: Biofilm antimicrobial susceptibility testing
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
134
March 2014
March 2014   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00786513
1000011132
No
Valerie Waters, The Hospital for Sick Children
The Hospital for Sick Children
Not Provided
Principal Investigator: Valerie Waters, MD The Hospital for Sick Children
Principal Investigator: Yvonne Yau, MD The Hospital for Sick Children
The Hospital for Sick Children
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP