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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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Chapel Hill, North Carolina 27599
(919) 962-2211
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
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234 Goodman Dr
Cincinnati, Ohio 45229
(513) 584-1000
University of Cincinnati Medical Center Opening in 1823 as the country
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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Los Angeles, California 90033
213) 740-2311
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Minneapolis, Minnesota 55455
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Philadelphia, Pennsylvania 19134
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
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47 New Scotland Ave
Albany, New York 12208
(518) 262-3125
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Altamonte, Florida 32701
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Anchorage, Alaska 99508
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
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Denver, Colorado 80218
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1400 Jackson St
Denver, Colorado 80206
(303) 388-4461
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705 Riley Hospital Dr
Indianapolis, Indiana 46202
(317) 944-5000
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Las Vegas, Nevada 89107
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9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
(414) 266-2000
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
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Minneapolis, Minnesota 55404
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630 W 168th St
New York, New York
212-305-2862
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Orlando, Florida 32806
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2900 W Queen Ln
Philadelphia, Pennsylvania 19129
(215) 991-8100
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3451 Walnut St
Philadelphia, Pennsylvania 19104
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Tucson, Arizona 85721
(520) 621-2211
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