Registry to Monitor the Susceptibility to Aztreonam of Pseudomonas Aeruginosa Isolates From Cystic Fibrosis Patients (AIR-CF5)
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Purpose
This is a 5-year study that will enroll 500 subjects from the existing Cystic Fibrosis Foundation (CFF) patient registry. Eligible subjects will be patients who receive care at CFF-accredited centers nationwide. Each enrolled subject will provide samples for microbiological evaluation, obtained upon enrollment and then once per year thereafter for 5 years.
| Condition |
|---|
|
Cystic Fibrosis |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| 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] |
- Changes in susceptibility among Pseudomonas aeruginosa (PA) isolates to aztreonam [ Time Frame: 5 years ] [ Designated as safety issue: No ]To determine whether there are any changes in susceptibility to aztreonam among Pseudomonas aeruginosa (PA) isolates from subjects with cystic fibrosis (CF) in the United States over the five year period after introduction of Cayston® (aztreonam for inhalation solution).
- Determine whether changes in clinical outcomes are associated with changes in susceptibility of PA isolates to aztreonam. [ Time Frame: 5 years ] [ Designated as safety issue: No ]The secondary objective is to determine whether any changes in susceptibility are associated with changes in clinical outcomes, including changes in lung function, number and duration of hospitalizations, and body mass index (BMI).
Biospecimen Retention: Samples Without DNA
Pseudomonas aeruginosa isolates from sputum or throat swab specimens
| Estimated Enrollment: | 500 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | February 2017 |
| Estimated Primary Completion Date: | August 2016 (Final data collection date for primary outcome measure) |
This is a prospective, longitudinal study that will enroll a subset of subjects from the existing Cystic Fibrosis Foundation (CFF) patient registry, which includes more than 25,500 patients who receive care at CFF-accredited centers nationwide. This will be a 5-year study embedded within the CFF registry that will include collection of lower respiratory tract samples from 500 subjects each year. These samples for microbiological evaluation will be obtained from each subject upon enrollment and then once per year thereafter.
Eligibility| Ages Eligible for Study: | 6 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
A representative cross-section of subjects with mild (FEV1 75% to
≤ 90% predicted), moderate (FEV1 40% to 74% predicted), or severe (FEV1 <40% predicted) lung disease and a history of ≥ 2 lower respiratory tract cultures positive for PA (at any time)will be enrolled. This will include approximately 100 subjects with pre-study exposure to Cayston (defined as having received at least one prior 28-day course of Cayston at any time before enrolling into the study). Enrollment will be monitored and potentially modified to ensure that adequate numbers of subjects in each disease severity category are included. At the Investigator's discretion, subjects enrolled in this study can be allowed to participate in clinical trials with other investigational therapies as appropriate.
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.
Contacts and Locations
Show 31 Study Locations| Study Director: | Mark Bresnik, MD | Gilead Sciences |
More Information
No publications provided
| Responsible Party: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT01375036 History of Changes |
| Other Study ID Numbers: | GX-US-205-0128 |
| Study First Received: | June 15, 2011 |
| Last Updated: | December 13, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Gilead Sciences:
|
Cystic fibrosis PA Pseudomonas aeruginosa CF aztreonam |
Additional relevant MeSH terms:
|
Cystic Fibrosis Disease Susceptibility Genetic Predisposition to Disease Fibrosis Pseudomonas Infections Pancreatic Diseases Digestive System Diseases Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn |
Infant, Newborn, Diseases Disease Attributes Pathologic Processes Gram-Negative Bacterial Infections Bacterial Infections Aztreonam Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013