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Study Evaluating Antibiotic Utilization Measures and Control of Extended-Spectrum-Lactamases (ESBLs)

Last updated on October 13, 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.
Bacterial Infection
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

- Patients admitted or transferred to the ICU/pulmonary/hematology units.

- Patients of either sex, 18 years of age or older

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

- Pregnant and nursing women. Female of childbearing potential without using any birth
control methods. Female of childbearing potential using oral contraceptives during
study period. (Note: penicillin and beta-lactamase inhibitors may prevent oral
contraceptives from working properly, increasing the chance of pregnancy).

- Patients who have the contraindications of using Tazocin (pipercillin/tazobactam)

Other exclusions apply.

NCT00254696
Pfizer
Completed
Study Evaluating Antibiotic Utilization Measures and Control of Extended-Spectrum-Lactamases (ESBLs)

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Descriptive Information
Brief Title  ICMJE Study Evaluating Antibiotic Utilization Measures and Control of Extended-Spectrum-Lactamases (ESBLs)
Official Title  ICMJE Association of Antibiotic Utilization Measures and Control of Extended-spectrum-lactamases (ESBLs)
Brief Summary
  • To determine the value of using piperacillin/tazobactam in reducing the cases of ESBL producing E. coli or K. pneumoniae colonization and infection.
  • To determine the acquisition rate of ESBL producing E. coli or K. pneumoniae, both pre and post intervention in the selected medical centers.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Bacterial Infection
Intervention  ICMJE Drug: Extended-Spectrum-Lactamases (ESBLs)
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: April 13, 2011)
710
Original Enrollment  ICMJE
 (submitted: November 14, 2005)
1000
Actual Study Completion Date  ICMJE March 2005
Actual Primary Completion DateMarch 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients admitted or transferred to the ICU/pulmonary/hematology units.
  • Patients of either sex, 18 years of age or older

Exclusion Criteria:

  • Pregnant and nursing women. Female of childbearing potential without using any birth control methods. Female of childbearing potential using oral contraceptives during study period. (Note: penicillin and beta-lactamase inhibitors may prevent oral contraceptives from working properly, increasing the chance of pregnancy).
  • Patients who have the contraindications of using Tazocin (pipercillin/tazobactam)

Other exclusions apply.

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 Countries  
 
Administrative Information
NCT Number  ICMJE NCT00254696
Other Study ID Numbers  ICMJE 0910X-101462
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyNot Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator:Trial ManagerFor China [email protected]
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateApril 2011

ICMJE     Data element required by the

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

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

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[email protected]

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