- Male and female subjects aged ≥ 18, requiring intensive care treatment related to
secondary nosocomial sepsis, who require potent broad spectrum intravenous antibiotic
therapy.
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Pharmacoeconomic Analysis of First Line Meropenem Versus Standard Antibiotic Treatment in Seriously Infected Secondary Nosocomial Sepsis Syndrome Patients.
NCT00318552
Last updated on
December 15, 2017
About this Study
This study will directly compare meropenem with standard first line antibiotic therapies in
subjects entering an ICU with secondary nosocomial sepsis, or who contract sepsis while
resident in an ICU.
Eligibility criteria
Condition
Sepsis
Sex
Females and Males
Age
18+ years
Inclusion criteria
Show details
Exclusion criteria
Show details
NCT00318552
Pfizer
Completed
Pharmacoeconomic Analysis of First Line Meropenem Versus Standard Antibiotic Treatment in Seriously Infected Secondary Nosocomial Sepsis Syndrome Patients.
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Descriptive Information | ||||
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Brief Title ICMJE | Pharmacoeconomic Analysis of First Line Meropenem Versus Standard Antibiotic Treatment in Seriously Infected Secondary Nosocomial Sepsis Syndrome Patients. | |||
Official Title ICMJE | Pharmacoeconomic Analysis of First Line Meropenem Versus Standard Antibiotic Treatment in Seriously Infected Secondary Nosocomial Sepsis Syndrome Patients. An Open, Randomized Multi-center Study. | |||
Brief Summary | This study will directly compare meropenem with standard first line antibiotic therapies in subjects entering an ICU with secondary nosocomial sepsis, or who contract sepsis while resident in an ICU. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Sepsis | |||
Intervention ICMJE | Drug: Meropenem | |||
Study Arms | 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. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE | 160 | |||
Completion Date | June 2006 | |||
Primary Completion Date | June 2006 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria: |
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Hungary | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00318552 | |||
Other Study ID Numbers ICMJE | 3591/9014 D9211C09014 ( Other Identifier: AZ IMPACT ) |
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Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | August 2017 | |||
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 thte study website. To get updates and notications about this trail, sign up using the form below.
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Pfizer Clinical Trials Contact Center
1-800-718-1021