Registry to Monitor the Susceptibility to Aztreonam of Pseudomonas Aeruginosa Isolates From Cystic Fibrosis Patients (AIR-CF5)
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|ClinicalTrials.gov Identifier: NCT01375036|
Recruitment Status : Completed
First Posted : June 17, 2011
Last Update Posted : January 11, 2017
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|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||510 participants|
|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|
- 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.
- 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
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|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|
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.
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
|Study Director:||Gilead Study Director||Gilead Sciences|
|Responsible Party:||Gilead Sciences|
|Other Study ID Numbers:||
|First Posted:||June 17, 2011 Key Record Dates|
|Last Update Posted:||January 11, 2017|
|Last Verified:||January 2017|
Digestive System Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Gram-Negative Bacterial Infections
Bacterial Infections and Mycoses