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 |
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.
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.
We found this trial at
30
sites
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University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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University of Chicago One of the world's premier academic and research institutions, the University of...
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University of Cincinnati Medical Center Opening in 1823 as the country
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Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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University of Southern California The University of Southern California is one of the world’s leading...
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Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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University of Utah Research is a major component in the life of the U benefiting...
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Albany Medical College Albany Medical Center is northeastern New York's only academic health sciences center...
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171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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National Jewish Health National Jewish Health is known worldwide for treatment of patients with respiratory,...
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Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
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9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
Milwaukee, Wisconsin 53226
(414) 266-2000
Children's Hospital of Wisconsin Nothing matters more than our children. At Children's Hospital of Wisconsin,...
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Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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2900 W Queen Ln
Philadelphia, Pennsylvania 19129
Philadelphia, Pennsylvania 19129
(215) 991-8100
Drexel University College of Medicine Drexel University College of Medicine represents the consolidation of two...
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Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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University of Arizona The University of Arizona is a premier, public research university. Established in...
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