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Study Evaluating Antibiotic Use in Reducing Vancomycin-Resistant Enterococci and ESBL Producing Escherichia Coli and Klebsiella Pneumoniae in Intensive Care

Last updated on March 26, 2020

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Study Location
Gyunggi-do, , 431-070 Korea, Republic of
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Escherichia Coli Infections, Klebsiella 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.
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- All patients admitted to or transferred to the MICU.

- Patients 18 years of age or older.

- Provide written informed consent.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Patients known to be infected or colonized by VRE or ESBL-producing E.coli,
K.pneumoniae.

- Patients who have hypersensitivity to penicillin.

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

- Any concurrent condition or medication which would interfere with absorption or
metabolism of study drugs.

NCT00167986
Pfizer
Completed
Study Evaluating Antibiotic Use in Reducing Vancomycin-Resistant Enterococci and ESBL Producing Escherichia Coli and Klebsiella Pneumoniae in Intensive Care

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Descriptive Information
Brief Title Study Evaluating Antibiotic Use in Reducing Vancomycin-Resistant Enterococci and ESBL Producing Escherichia Coli and Klebsiella Pneumoniae in Intensive Care
Official Title Antibiotic Intervention Trial in a Medical Intensive Care Unit to Reduce the Acquisition of Vancomycin-Resistant Enterococci and ESBL Producing Escherichia Coli and Klebsiella Pneumoniae.
Brief Summary To determine whether the restriction of 3rd generation cephalosporins and carbapenems contribute to the reduction of intestinal colonization or infection with vancomycin-resistant enterococci (VRE) in a medical intensive care unit (MICU).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case Control
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition
  • Escherichia Coli Infections
  • Klebsiella Infections
Intervention Drug: vancomycin-resistant enterococci and ESBL
Study Groups/Cohorts 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 Completed
Enrollment
 (submitted: September 11, 2005)
480
Original Enrollment Same as current
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility Criteria

Inclusion Criteria:

  • All patients admitted to or transferred to the MICU.
  • Patients 18 years of age or older.
  • Provide written informed consent.

Exclusion Criteria:

  • Patients known to be infected or colonized by VRE or ESBL-producing E.coli, K.pneumoniae.
  • Patients who have hypersensitivity to penicillin.
  • Any underlying conditions or diseases that will be ultimately fatal within 48 hours.
  • Any concurrent condition or medication which would interfere with absorption or metabolism of study drugs.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT00167986
Other Study ID Numbers 101498
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators Not Provided
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date March 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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