Registry to Monitor the Susceptibility to Aztreonam of Pseudomonas Aeruginosa Isolates From Cystic Fibrosis Patients



Status:Active, not recruiting
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:6 - Any
Updated:4/21/2016
Start Date:August 2011
End Date:November 2016

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A Prospective, 5-year Registry Study to Monitor the Susceptibility to Aztreonam of Pseudomonas Aeruginosa (PA) Isolates From Patients With Cystic Fibrosis in the United States [AIR-CF5]

This is a prospective, longitudinal, 5-year study that will enroll participants from the
existing Cystic Fibrosis Foundation (CFF) patient registry. Each enrolled participant will
provide samples for microbiological evaluation, obtained upon enrollment and then once per
year thereafter for 5 years.


Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be eligible for
participation in this study.

- Current participant or willingness to participate in the CFF patient registry
database

- ≥ 6 years of age

- Subject has CF as diagnosed by one of the following

- Documented sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis
test, or

- Two well-characterized genetic mutations in the CFTR gene, or

- Abnormal nasal potential difference (NPD) AND accompanying clinical
characteristics consistent with CF. For subjects who lack documentation of
either a positive sweat chloride test or an abnormal NPD, and who have only one
well-characterized genetic mutation of the CFTR gene, the diagnosis of CF is
determined by the Investigator.

- FEV1 ≥ 25% predicted and ≤ 90% predicted.

- ≥ 2 lower respiratory tract cultures positive for PA with results documented in the
subject's medical history.

- Subject must be able to provide written informed consent/assent prior to any study
related procedure; parent/guardian must be able to give written informed consent as
necessary prior to any study related procedure.

Exclusion Criteria:

Subjects who meet the following exclusion criterion are not to be enrolled in this study.

• Any serious active medical or psychiatric illness that, in the opinion of the
Investigator, would interfere with subject assessment.
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Chapel Hill, North Carolina 27599
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5801 South Ellis Avenue
Chicago, Illinois 60637
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234 Goodman Dr
Cincinnati, Ohio 45229
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University of Cincinnati Medical Center Opening in 1823 as the country
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700 Childrens Drive
Columbus, Ohio 43205
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1200 Moursund Street
Houston, Texas 77030
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4650 Sunset Blvd
Los Angeles, California 90027
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Philadelphia, Pennsylvania 19134
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201 Presidents Circle
Salt Lake City, Utah 84108
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47 New Scotland Ave
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Altamonte, Florida 32701
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171 Ashley Avenue
Charleston, South Carolina 29425
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630 W 168th St
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