NCT00799591

French Study In ICU Patients Treated With Tigecycline

French Prospective Observational Study In Intensive Care Unit (ICU) Patients Treated With Tigecycline

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 156 (actual)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will describe clinical outcome and safety data collected prospectively in subjects hospitalized in an intensive care unit (ICU) presenting with an infection for which treatment with tigecycline, alone or in combination, is planned. Data will be collected only from subjects providing informed consent.

Detailed description

Healthcare visit. Extension Rationale: In order to perform the necessary corrective actions required and to secure database consistency, we request an extension for posting of Basic Results due 26-May-2011 for protocol 3074A1-4448 (B1811030), NCT00799591. Our proposed submission date is 14-Sept-2011. Pfizer acquired Wyeth on October 16, 2009. With regard to this study, our reconciliation of data identified some discrepancies in data listed in the Project database (managed by the CRO) and the Safety Database (managed by Pfizer). We are taking corrective action which involves: sending queries to investigators, collecting corrective signed forms, and implementing changes within the database. We are requesting this extension to complete that work so that the data can be treated as final and the CSR can be completed.

Conditions

• Bacterial Infections

Interventions

Type	Name	Description
OTHER	Observational study so no intervention in the patient.	Observational study so no intervention in the patient.

Timeline

• Start date: 2008-09-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2008-12-01
• Last updated: 2011-12-19
• Results posted: 2011-12-19

Locations

1 site across 1 country: France