French Study In ICU Patients Treated With Tigecycline

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00799591
First received: November 26, 2008
Last updated: November 15, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention
Bacterial Infections
Other: Observational study so no intervention in the patient.

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: French Prospective Observational Study In Intensive Care Unit (ICU) Patients Treated With Tigecycline

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline (Inclusion) through last dose of study treatment or up to 25 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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 [ 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Post-baseline (Day 1) through last dose of study treatment or up to 25 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Post-baseline (Day 1) through last dose of study treatment or up to 25 months ] [ Designated as safety issue: No ]
    Microbiological sampling results categorized according to direct examination (identification of the class of germs).


Enrollment: 156
Study Start Date: September 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Intensive Care
Other: Observational study so no intervention in the patient.
Observational study so no intervention in the patient.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Intensive Care Unit

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00799591

Locations
France
Pfizer Investigational Site
Paris, France, 75018
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Wyeth is now a wholly owned subsidiary of Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00799591     History of Changes
Other Study ID Numbers: 3074A1-4448, B1811030
Study First Received: November 26, 2008
Results First Received: September 8, 2011
Last Updated: November 15, 2011
Health Authority: France: Institutional Ethical Committee

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Registre MONTRAVERS

Additional relevant MeSH terms:
Bacterial Infections
Tigecycline
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014