French Study In ICU Patients Treated With Tigecycline

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Bacterial Infections

Intervention / Treatment
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* Other: Observational study so no intervention in the patient.


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Intensive Care | Other: Observational study so no intervention in the patient.<br>* Observational study so no intervention in the patient.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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. | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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. | 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 | 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. | 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 | Microbiological sampling results categorized as a positive blood culture (presence of infection). | 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 | Microbiological sampling results categorized according to direct examination (identification of the class of germs). | Post-baseline (Day 1) through last dose of study treatment or up to 25 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Registre MONTRAVERS