An observational study in Cystic Fibrosis and Pseudomonas Aeruginosa, sponsored by Indiana University. Completed at 1 site in United States. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2015-11-06.
Sponsored by Indiana University · Observational
This is a pilot study of inhaled antibiotic regimens is a pilot study examining clinical and laboratory endpoints of patients on inhaled antibiotic treatments. We hypothesize that alternation therapy utilizing Cayston and Tobi will inhibit antibiotic resistance and that alternation therapy will result in a decreased incidence of antibiotic resistance to Cystic Fibrosis (CF) microbial isolates. The long term strategic goal is to develop a model biometric system for selecting a patient's optimal inhaled antibiotic regimen by utilizing clinical and microbiological parameters.
97 studies on the registry are indexed under Pseudomonas Infections; 23 are open to participants now.
This study's enrollment of 27 is below the median of 100 across 32 observational studies indexed under Pseudomonas Infections.
Browse Pseudomonas Infections studies →Indiana University is the lead sponsor of 958 studies on the registry; 200 are open to participants now.
Of its 142 completed or terminated interventional studies of FDA-regulated products, 112 (79%) have results posted.
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Primary care clinic
Exclusion Criteria:
This cohort will be on a previously established medication regiment of Cayston inhaled antibiotic alternating regimen every other month.
This Cohort will be on a previously established medication regiment that includes Tobi inhaled antibiotic regimen alternating every other month.
This Cohort will be on a previously established medication regiment that includes Cayston and Tobi inhaled antibiotic alternating every other month
Antibiotic Resistance Profiles
The primary endpoint will be a change in the microbial resistance profile of pseudomonas aeruginosa (PA)isolates, change in PA sputum density, minimum inhibitory concentration of aztreonam and tobramycin for PA and the appearance or disappearance of other pathogens.
Time frame: Every three months within a 12 month period
Clinical Symptoms
Secondary endpoint will be the change in clinical symptoms as assessed by the respiratory symptoms domain of the Cystic Fibrosis Questionnaire -Revised (CFQ-R),changes in pulmonary function Forced Exhaled Volume 1 second (FEV1) and change in frequency of hospitalizations or need for intravenous antibiotics.
Time frame: Every 3 months within a 12 month period
This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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Indiana University