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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

Page last updated: August 23, 2015

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