Assess Increased Mortality Risk With Each Year of Delayed Tobramycin Solution (TIS) Initiation, and Effect of TIS on Mortality Across Study Centers
Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cystic Fibrosis
Phase: N/A
Status: Active, not recruiting
Sponsored by: Novartis Pharmaceuticals Official(s) and/or principal investigator(s): Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals
Summary
Using CFF registry data, this analysis will: describe patterns of time to TIS initiation
from first year of TIS eligibility, estimate the increased risk of death attributable to
each year of delayed TIS initiation, and investigate TIS effects across study centers.
Clinical Details
Official title: Assess the Increased Mortality Risk With Each Year of Delayed TIS Initiation, and the Effect of TIS on Mortality Across Study Centers
Study design: Observational Model: Cohort, Time Perspective: Retrospective
Primary outcome: Time to tobramycin solution (TIS) initiation from first year of TIS eligibility
Secondary outcome: Mortality
Eligibility
Minimum age: 6 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- ≥6 years of age with a documented Cystic fibrosis (CF) diagnosis,
- moderate-to-severe lung disease,
- Pseudomonas aeruginosa (PA) airway infection.
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Locations and Contacts
Additional Information
Starting date: March 2011
Last updated: October 25, 2011
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