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| Tracking Information | |||||||||
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| First Received Date ICMJE | August 31, 2007 | ||||||||
| Last Updated Date | April 7, 2009 | ||||||||
| Start Date ICMJE | July 2007 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00524563 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Clinical Outcomes and Global Epidemiology -Data Coordinating Center | ||||||||
| Official Title ICMJE | Clinical Outcomes and Global Epidemiology -Data Coordinating Center | ||||||||
| Brief Summary | The primary objective is to assess for independent predictors of in-hospital mortality (up to 28 days) in patients with Acinetobacter bloodstream infection. Secondary Objectives include the following: To determine the impact of inactive empiric antimicrobial therapy, defined as receipt of empiric antimicrobial therapy with no in vitro activity against the offending isolate for at least 24hrs, on the outcome (end points defined below) of patients with Acinetobacter bloodstream infection. To determine the impact of carbapenem resistance and pan-drug resistance (defined as resistance to all antimicrobials except colistin and/or tigecycline if these agents were tested) on the outcome of patients with Acinetobacter bloodstream infection. To assess the efficacy of varying definitive therapies on the outcome of patients with Acinetobacter bloodstream infection. To characterize the molecular epidemiology of Acinetobacter on a global level, as determined by pulsed-field gel electrophoresis (PFGE) and other techniques, and to assess whether patient outcomes are clonally related and to characterize the mechanisms of resistance in Acinetobacter on a global scale. |
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| Detailed Description | Medical records will be reviewed and information collected from charts to assess for independent predictors of in-hospital mortality (up to 28 days) in patients with Acinetobacter bloodstream infection. 24 sites will participate and all information will be loaded into a password protected database. |
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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Cohort, Retrospective | ||||||||
| Condition ICMJE | Acinetobacter Infections | ||||||||
| Intervention ICMJE | |||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 400 | ||||||||
| Completion Date | |||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00524563 | ||||||||
| Responsible Party | David Paterson MD, UPMC | ||||||||
| Study ID Numbers ICMJE | PRO07080042 | ||||||||
| Study Sponsor ICMJE | University of Pittsburgh | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | University of Pittsburgh | ||||||||
| Verification Date | April 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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