A Phase 2 interventional study of Conventional antimicrobial susceptibility testing and Biofilm antimicrobial susceptibility testing in Cystic Fibrosis, sponsored by The Hospital for Sick Children. Completed at 5 sites in Canada. Per ClinicalTrials.gov, last updated 2014-04-04.
Sponsored by The Hospital for Sick Children · Phase 2, Interventional, and Treatment
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.
1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.
This study's enrollment of 134 is above the median of 36 across 1,034 interventional studies indexed under Cystic Fibrosis.
Browse Cystic Fibrosis studies →The Hospital for Sick Children is the lead sponsor of 568 studies on the registry; 81 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other: Conventional antimicrobial susceptibility testing
Other: Biofilm 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.
Subjects in this arm will be prescribed 14 days of an intravenous 2 drug antibiotic combination based on biofilm antimicrobial susceptibility testing results.
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
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
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
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
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
This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.
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