French Study In ICU Patients Treated With Tigecycline

Wyeth is now a wholly owned subsidiary of Pfizer156 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

156

Conditions

Bacterial Infections

Interventions

Observational study so no intervention in the patient.OTHER

Observational study so no intervention in the patient.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Pfizer Investigational Site

Paris, France

Outcomes

Primary Outcomes

Percentage of Participants Per Clinical Outcome (Success, Failure, or Undetermined) at End of Treatment (EOT)

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.

Time frame: End of Treatment (on the day of last dose of study treatment) or up to 25 months

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

Secondary Outcomes

Percentage of Participants Per Tigecycline Loading Dose and Maintenance Dose

Tigecycline powder for solution 50 milligrams (mg) for intravenous (IV) infusion could be administered with an initial loading dose of 100 mg followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days. Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity.

Data from ClinicalTrials.gov

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