French Prospective Observational Study In Intensive Care Unit (ICU) Patients Treated With Tigecycline
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bacterial Infections
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Enrollment
- 156
- Locations
- 1
- Primary Endpoint
- Percentage of Participants Per Clinical Outcome (Success, Failure, or Undetermined) at End of Treatment (EOT)
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adult men and women (18 years).
- •Subjects hospitalized in a medical or surgical intensive care unit (ICU) (on the day of enrolment in the study).
- •Subjects treated with tigecycline (first, second or third line), said treatment freely chosen by the participating physician, prior to enrollment in the study.
Exclusion Criteria
- •Subjects participating in another biomedical research study.
- •Patient (or legal representative) who has not dated or signed informed consent document.
Outcomes
Primary Outcomes
Percentage of Participants Per Clinical Outcome (Success, Failure, or Undetermined) at End of Treatment (EOT)
Time Frame: End of Treatment (on the day of last dose of study treatment) or up to 25 months
Clinical Success: lack of need to use new antibiotic or a surgical treatment not initially planned for initial infection. Failure: persistence of initial infection (required change of antibiotic or surgery), death related to infection (\>48 hours after start of treatment with tigecycline), or premature cessation of treatment due to treatment-related Adverse Event. Undetermined: insufficient data for assessment, death not directly related to initial infection, death within first 48 hours of start of treatment with tigecycline, or additional antibiotic treatment for other than initial infection.
Percentage of Participants Per Clinical Outcome (Success, Failure, or Undetermined) at Follow-up Visit
Time Frame: Follow-up Visit (7 days after last dose or at hospital discharge whichever occurred within 7 days after last dose) or up to 25 months
Clinical Success: lack of need to use new antibiotic or a surgical treatment not initially planned for initial infection. Failure: persistence of initial infection (required change of antibiotic or surgery), death related to infection (\>48 hours after start of treatment with tigecycline), or premature cessation of treatment due to treatment-related Adverse Event. Undetermined: insufficient data for assessment, death not directly related to initial infection, death within first 48 hours of start of treatment with tigecycline, or additional antibiotic treatment for other than initial infection.
Secondary Outcomes
- Percentage of Participants Per Tigecycline Loading Dose and Maintenance Dose(Baseline (Inclusion) through last dose of study treatment or up to 25 months)
- Mean Duration (Days) of Treatment With Tigecycline(Baseline (Inclusion) through last dose of study treatment or up to 25 months)
- Percentage of Participants (> 10%) With Use of Other Antibiotics in Combination With Tigecycline Who Had Clinical Success at EOT(Baseline (Inclusion), End of Treatment (on the day of last dose of study treatment) or up to 25 months)
- Percentage of Participants (> 10%) With Use of Other Antibiotics in Combination With Tigecycline Who Had Clinical Success at Follow-up Visit(Baseline (Inclusion), Follow-up Visit (7 days after last dose or at hospital discharge whichever occurred within 7 days after last dose) or up to 25 months)
- Percentage of Participants With Microbiological Sampling Results During Treatment Phase With Tigecycline: Positive Blood Culture(Post-baseline (Day 1) through last dose of study treatment or up to 25 months)
- Percentage of Participants With Microbiological Sampling Results During Treatment Phase With Tigecycline: Direct Examination(Post-baseline (Day 1) through last dose of study treatment or up to 25 months)