Assess Increased Mortality Risk With Each Year of Delayed Tobramycin Solution (TIS) Initiation, and Effect of TIS on Mortality Across Study Centers

Withdrawn

• Conditions: Cystic Fibrosis

• Registration Number: NCT01460849
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Study First Submitted: 2011-10-25
• Study First Submitted QC: 2011-10-25
• Study First Posted: 2011-10-27
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-23
• Last Update Posted: 2021-12-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to tobramycin solution (TIS) initiation from first year of TIS eligibility

Secondary Outcome Measures

Name	Time	Method
Mortality