French Study In ICU Patients Treated With Tigecycline

Completed

Conditions: Bacterial Infections

Registration Number: NCT00799591

Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 156

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.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

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

Name	Time	Method
Percentage of Participants Per Tigecycline Loading Dose and Maintenance Dose	Baseline (Inclusion) through last dose of study treatment or up to 25 months	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.
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	Combinations of antibiotic treatments for participants treated with clinical success with tigecycline. Clinical success defined as lack of need to use new antibiotic or a surgical treatment not initially planned for initial infection.
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	Combinations of antibiotic treatments for participants treated with clinical success with tigecycline. Clinical success defined as lack of need to use new antibiotic or a surgical treatment not initially planned for initial infection.
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	Microbiological sampling results categorized as a positive blood culture (presence of infection).
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	Microbiological sampling results categorized according to direct examination (identification of the class of germs).