Trial record 1 of 10 for:
AIR CF 5
Registry to Monitor the Susceptibility to Aztreonam of Pseudomonas Aeruginosa Isolates From Cystic Fibrosis Patients (AIR-CF5)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01375036 |
|
Recruitment Status :
Completed
First Posted : June 17, 2011
Last Update Posted : January 11, 2017
|
Sponsor:
Gilead Sciences
Collaborator:
Cystic Fibrosis Foundation
Information provided by (Responsible Party):
Gilead Sciences
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief 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.
| Condition or disease |
|---|
| Cystic Fibrosis |
| Study Type : | Observational |
| Actual Enrollment : | 510 participants |
| 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] |
| Study Start Date : | August 2011 |
| Actual Primary Completion Date : | December 2016 |
| Actual Study Completion Date : | December 2016 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Cystic fibrosis
MedlinePlus related topics:
Cystic Fibrosis
Primary Outcome Measures :
- 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) [ Time Frame: Up to 5 years ]This proportion will be compared annually over 5 years.
Secondary Outcome Measures :
- Annual mean change and mean change from baseline in FEV1 (liters) and FEV1 % predicted [ Time Frame: Baseline to Year 5 ]
- Annual number of hospitalizations and the total number of hospitalizations at the end of each year [ Time Frame: Up to 5 years ]
- Annual number of days hospitalized and the total number of hospitalization days at the end of each year [ Time Frame: Up to 5 years ]
- Annual mean change and mean change from baseline in body mass index (BMI) [ Time Frame: Baseline to Year 5 ]
- 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 [ Time Frame: Up to 5 years ]
Biospecimen Retention: Samples Without DNA
Pseudomonas aeruginosa isolates from sputum or throat swab specimens
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 6 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
A representative cross-section of individuals 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 individuals 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 participants in each disease severity category are included. At the Investigator's discretion, participants enrolled in this study can be allowed to participate in clinical trials with other investigational therapies as appropriate.
Criteria
Key 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.
Key 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.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01375036
Locations
Show 31 study locations
Sponsors and Collaborators
Gilead Sciences
Cystic Fibrosis Foundation
Investigators
| Study Director: | Gilead Study Director | Gilead Sciences |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT01375036 |
| Other Study ID Numbers: |
GX-US-205-0128 |
| First Posted: | June 17, 2011 Key Record Dates |
| Last Update Posted: | January 11, 2017 |
| Last Verified: | January 2017 |
Keywords provided by Gilead Sciences:
|
Cystic fibrosis PA Pseudomonas aeruginosa CF aztreonam |
Additional relevant MeSH terms:
|
Pseudomonas Infections Cystic Fibrosis Fibrosis Pathologic Processes Pancreatic Diseases Digestive System Diseases Lung Diseases |
Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Gram-Negative Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Infections |