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Study Evaluating Vancomycin-Resistant Enterococci in a Hematology Unit

Last updated on October 18, 2019

FOR MORE INFORMATION
Study Location
Incheon, , 405-760 Korea, Republic of
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Gram-Positive Bacterial Infections
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.
Show details

- All patients admitted to or transferred to the SICU.

- Eligible patients will be patients of either sex, 18 years of age or older who are
admitted or transferred to the SICU.

- Provide written informed consent

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

- Patients who have hypersensitivity to penicillin, cephalosporins or beta-lactamase
inhibitors.

- Females who are pregnant and breast feeding

- Any underlying conditions or non-infectious diseases that will be ultimately fatal
within 48 hours.

- Those who have already been participating other clinical study related with
antibiotics.

NCT00167960
Pfizer
Completed
Study Evaluating Vancomycin-Resistant Enterococci in a Hematology Unit

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Descriptive Information
Brief TitleStudy Evaluating Vancomycin-Resistant Enterococci in a Hematology Unit
Official TitleEffects on the Emergence and Transmission of Vancomycin-Resistant Enterococci After Changes in Antibiotic Use in a Hematology Unit.
Brief SummaryTo determine the impact of the restriction of the third and forth generation cephalosporins on the reduction of intestinal colonization or infection with vancomycin-resistant enterococci (VRE) in a surgical intensive care unit (SICU)
Detailed DescriptionNot Provided
Study TypeObservational
Study DesignObservational Model: Case Control
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNot Provided
Study PopulationNot Provided
ConditionGram-Positive Bacterial Infections
InterventionDrug: Piperacillin/tazobactam and other ?-lactam/?-lactamase
Study Groups/CohortsNot 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 StatusCompleted
Enrollment
 (submitted: September 11, 2005)
1500
Original EnrollmentSame as current
Study Completion DateNot Provided
Primary Completion DateNot Provided
Eligibility Criteria

Inclusion Criteria:

  • All patients admitted to or transferred to the SICU.
  • Eligible patients will be patients of either sex, 18 years of age or older who are admitted or transferred to the SICU.
  • Provide written informed consent

Exclusion Criteria:

  • Patients who have hypersensitivity to penicillin, cephalosporins or beta-lactamase inhibitors.
  • Females who are pregnant and breast feeding
  • Any underlying conditions or non-infectious diseases that will be ultimately fatal within 48 hours.
  • Those who have already been participating other clinical study related with antibiotics.
Sex/Gender
Sexes Eligible for Study:All
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesKorea, Republic of
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00167960
Other Study ID Numbers0910X-101525
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyNot Provided
Study SponsorWyeth is now a wholly owned subsidiary of Pfizer
CollaboratorsNot Provided
Investigators
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateMarch 2007

FOR MORE INFORMATION

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

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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