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Completed

NCT Number: NCT00799591

French Study In ICU Patients Treated With Tigecycline

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.

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Key information

Conditions

Bacterial Infections Bacterial Infections and Mycoses Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer Investigational Site

Paris, 75018, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Observational study so no intervention in the patient.

Other

Observational study so no intervention in the patient.

Primary outcomes

  1. 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.

  2. 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

  1. Percentage of Participants Per Tigecycline Loading Dose and Maintenance Dose

    Time frame: 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.

  2. Mean Duration (Days) of Treatment With Tigecycline

    Time frame: Baseline (Inclusion) through last dose of study treatment or up to 25 months

  3. Percentage of Participants (> 10%) With Use of Other Antibiotics in Combination With Tigecycline Who Had Clinical Success at EOT

    Time frame: 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.

  4. Percentage of Participants (> 10%) With Use of Other Antibiotics in Combination With Tigecycline Who Had Clinical Success at Follow-up Visit

    Time frame: 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.

  5. Percentage of Participants With Microbiological Sampling Results During Treatment Phase With Tigecycline: Positive Blood Culture

    Time frame: 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).

  6. Percentage of Participants With Microbiological Sampling Results During Treatment Phase With Tigecycline: Direct Examination

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Dec 1, 2008
Registry last updated
Dec 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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