Assess Increased Mortality Risk With Each Year of Delayed Tobramycin Solution (TIS) Initiation, and Effect of TIS on Mortality Across Study Centers
This study is ongoing, but not recruiting participants.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01460849
First received: October 25, 2011
Last updated: NA
Last verified: October 2011
History: No changes posted
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | October 25, 2011 | ||||
| Last Updated Date | October 25, 2011 | ||||
| Start Date ICMJE | March 2011 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Time to tobramycin solution (TIS) initiation from first year of TIS eligibility [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
Mortality [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Assess Increased Mortality Risk With Each Year of Delayed Tobramycin Solution (TIS) Initiation, and Effect of TIS on Mortality Across Study Centers | ||||
| Official Title ICMJE | Assess the Increased Mortality Risk With Each Year of Delayed TIS Initiation, and the Effect of TIS on Mortality Across Study Centers | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Cystic fibrosis |
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| Condition ICMJE | Cystic Fibrosis | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | Not Provided | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: Other protocol-defined inclusion/exclusion criteria may apply. |
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| Gender | Both | ||||
| Ages | 6 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01460849 | ||||
| Other Study ID Numbers ICMJE | HEORUS0088 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Novartis ( Novartis Pharmaceuticals ) | ||||
| Study Sponsor ICMJE | Novartis Pharmaceuticals | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Novartis | ||||
| Verification Date | October 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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