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Study Evaluating Tigecycline in Selected Serious Infections Caused by Vancomycin-Resistant Enterococcus (VRE) or Methicillin-Resistant Staphylococcus Aureus (MRSA)

Last updated on November 19, 2019

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Gram-Positive Bacterial Infections, Staphylococcus Infections, Vancomycin Resistance, Methicillin Resistance
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Male or female subjects aged 18 years or older

- Isolation of one of the following multi-antibiotic resistant bacteria:
vancomycin-resistant Enterococcus faecium, vancomycin-resistant Enterococcus
faecalis, or methicillin-resistant Staphylococcus aureus, alone or as part of a
polymicrobial infection

- Have a confirmed diagnosis of a serious infection (eg, bacteremia [unless due to an
excluded infection], complicated intra-abdominal infection, complicated skin and skin
structure infection, or pneumonia) requiring administration of intravenous (IV)
antibiotic therapy

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Subjects with any concomitant condition or taking any concomitant medication that, in
the opinion of the investigator, could preclude an evaluation of a response or make
it unlikely that the contemplated course of therapy or follow-up assessment will be
completed or that will substantially increase the risk associated with the subject's
participation in this study

- Anticipated length of antibiotic therapy less than 7 days

- For subjects with VRE, known or suspected hypersensitivity to tigecycline or
linezolid, or other compounds related to these classes of antibacterial agents (eg,
oxazolidinones, tetracyclines, minocycline, doxycycline). For subjects with MRSA,
known or suspected hypersensitivity to tigecycline or vancomycin, or other compounds
related to these classes of antibacterial agents (eg, tetracyclines, minocycline,
doxycycline)

NCT00079976
Pfizer
Completed
Study Evaluating Tigecycline in Selected Serious Infections Caused by Vancomycin-Resistant Enterococcus (VRE) or Methicillin-Resistant Staphylococcus Aureus (MRSA)

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Descriptive Information
Brief Title  ICMJE Study Evaluating Tigecycline in Selected Serious Infections Caused by Vancomycin-Resistant Enterococcus (VRE) or Methicillin-Resistant Staphylococcus Aureus (MRSA)
Official Title  ICMJE A Clinical Research Study to Evaluate the Safety and Efficacy of Tigecycline in the Treatment of Selected Serious Infections Caused by Vancomycin-Resistant Enterococcus (VRE) or Methicillin-Resistant Staphylococcus Aureus (MRSA)
Brief SummaryTo evaluate the safety and efficacy of tigecycline in the treatment of selected serious infections caused by VRE. The primary efficacy endpoint will be the clinical response for all subjects.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Gram-Positive Bacterial Infections
  • Staphylococcus Infections
  • Vancomycin Resistance
  • Methicillin Resistance
Intervention  ICMJE Drug: Tigecycline
Study Arms  ICMJE Not Provided
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 7, 2013)
174
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE June 2005
Actual Primary Completion DateJune 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female subjects aged 18 years or older
  • Isolation of one of the following multi-antibiotic resistant bacteria: vancomycin-resistant Enterococcus faecium, vancomycin-resistant Enterococcus faecalis, or methicillin-resistant Staphylococcus aureus, alone or as part of a polymicrobial infection
  • Have a confirmed diagnosis of a serious infection (eg, bacteremia [unless due to an excluded infection], complicated intra-abdominal infection, complicated skin and skin structure infection, or pneumonia) requiring administration of intravenous (IV) antibiotic therapy

Exclusion Criteria:

  • Subjects with any concomitant condition or taking any concomitant medication that, in the opinion of the investigator, could preclude an evaluation of a response or make it unlikely that the contemplated course of therapy or follow-up assessment will be completed or that will substantially increase the risk associated with the subject's participation in this study
  • Anticipated length of antibiotic therapy less than 7 days
  • For subjects with VRE, known or suspected hypersensitivity to tigecycline or linezolid, or other compounds related to these classes of antibacterial agents (eg, oxazolidinones, tetracyclines, minocycline, doxycycline). For subjects with MRSA, known or suspected hypersensitivity to tigecycline or vancomycin, or other compounds related to these classes of antibacterial agents (eg, tetracyclines, minocycline, doxycycline)
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location CountriesUnited States
 
Administrative Information
NCT Number  ICMJE NCT00079976
Other Study ID Numbers  ICMJE 3074A1-307
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyWyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical Monitor, MDWyeth is now a wholly owned subsidiary of Pfizer
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateFebruary 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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