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

Information source: Gilead Sciences
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cystic Fibrosis

Phase: N/A

Status: Active, not recruiting

Sponsored by: Gilead Sciences

Official(s) and/or principal investigator(s):
Mark Bresnik, MD, Study Director, Affiliation: Gilead Sciences

Summary

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.

Clinical Details

Official title: 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]

Study design: Time Perspective: Prospective

Primary outcome: Proportion of participants whose least susceptible Pseudomonas aeruginosa (PA) isolate has a ≥ 4-fold increase in aztreonam minimum inhibitory concentration over 1 year and is above the parenteral breakpoint (> 8 μg/mL)

Secondary outcome:

Annual mean change and mean change from baseline in FEV1 (liters) and FEV1 % predicted

Annual number of hospitalizations and the total number of hospitalizations at the end of each year

Annual number of days hospitalized and the total number of hospitalization days at the end of each year

Annual mean change and mean change from baseline in body mass index (BMI)

Annual number of Cayston treatment courses per participant and the total number of Cayston treatment courses at the end of each year in participants that used Cayston

Eligibility

Minimum age: 6 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Providence Alaska Medical Center, Anchorage, Alaska 99508, United States

University of Arizona, Tucson, Arizona 85724, United States

Arkansas Children's Hospital Research Institute, Little Rock, Arkansas 72202, United States

Children's Hospital of Los Angeles, Los Angeles, California 90027, United States

University of Southern California, Los Angeles, California 90033, United States

National Jewish Health, Denver, Colorado 80206, United States

The Children's Hospital, Denver, Colorado 80045, United States

Central Florida Pulmonary Group, Altamonte, Florida 32701, United States

Nemours Children's Clinic, Orlando, Florida 32801, United States

University of Chicago, Chicago, Illinois 60637, United States

Riley Hospital for Children, Indianapolis, Indiana 46202, United States

Massachusetts General Hospital, Boston, Massachusetts 02114, United States

Massachusetts General Hospital, Boston, Massachusetts 02115, United States

Children's Hospitals & Clinics of Minnesota, Minneapolis, Minnesota 55404, United States

University of Minnesota, Minneapolis, Minnesota 55455, United States

Children's Lung Specialists, Las Vegas, Nevada 89107, United States

Albany Medical College, Albany, New York 12208, United States

Columbia University Medical Center, New York, New York 10032, United States

University of North Carolina at Chapel Hill, Chapel Hill, North Carolina 27599, United States

Cincinati Children's Hosptial Medical Center, Cincinnati, Ohio 45229, United States

University of Cincinnati Medical Center, Cincinnati, Ohio 45267, United States

Nationwide Children's Hospital, Columbus, Ohio 43205, United States

The Children's Medical Center of Dayton, Dayton, Ohio 45404, United States

Drexel University College of Medicine, Philadelphia, Pennsylvania 19102, United States

St. Christopher's Hospital for Children, Philadelphia, Pennsylvania 19134, United States

University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States

Medical University of South Carolina, Charleston, South Carolina 29425, United States

Baylor College of Medicine, Houston, Texas 77030, United States

University of Utah, Salt Lake City, Utah 84132, United States

Children's Hospital of Wisconsin, Milwaukee, Wisconsin 53201, United States

Medical College of Wisconsin, Milwaukee, Wisconsin 53226, United States

Additional Information

Starting date: August 2011
Last updated: March 17, 2015

Page last updated: August 20, 2015

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