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

Assess the Increased Mortality Risk With Each Year of Delayed TIS Initiation, and the Effect of TIS on Mortality Across Study Centers

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01460849

Enrollment

Registered

2011-10-27

Start date

2011-03-31

Completion date

2011-03-31

Last updated

2021-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Keywords

Cystic fibrosis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Years to No maximum

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
Time to tobramycin solution (TIS) initiation from first year of TIS eligibility	—

Secondary

Measure	Time frame
Mortality	—

Outcome results